Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-26 @ 7:17 AM
Study NCT ID:
NCT03408392
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2018-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study Between SKF101804 Cefixime 200 Milligram (mg)/5 Milliliter (mL) Suspension Versus Cefixime 200 mg/5 mL Suspension Reference Product in Healthy Adult Subjects Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to Day 16 in each treatment period.', 'description': 'SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '20000', 'spread': '32.9', 'groupId': 'OG000'}, {'value': '19000', 'spread': '34.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.38', 'ciLowerLimit': '96.11', 'ciUpperLimit': '115.54', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bio-equivalence analysis comparing cefixime test and reference product has been presented.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period', 'description': 'Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.', 'unitOfMeasure': 'Hour*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '2670', 'spread': '29.4', 'groupId': 'OG000'}, {'value': '2640', 'spread': '30.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.14', 'ciLowerLimit': '93.37', 'ciUpperLimit': '109.55', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bio-equivalence analysis comparing cefixime test and reference product has been presented.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period', 'description': 'Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '20700', 'spread': '31.8', 'groupId': 'OG000'}, {'value': '19700', 'spread': '33.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.14', 'ciLowerLimit': '96.31', 'ciUpperLimit': '114.78', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bio-equivalence analysis comparing cefixime test and reference product has been presented.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period', 'description': 'Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.', 'unitOfMeasure': 'Hour*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Time of Occurrence of Cmax (Tmax) for Cefixime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.005', 'groupId': 'OG000', 'lowerLimit': '2.50', 'upperLimit': '6.02'}, {'value': '4.005', 'groupId': 'OG001', 'lowerLimit': '2.02', 'upperLimit': '4.51'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period', 'description': 'Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of cefixime was analyzed using a nonparametric test to compute point estimate of the median and full range.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.24', 'spread': '51.4', 'groupId': 'OG000'}, {'value': '3.32', 'spread': '67.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period', 'description': 'Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.', 'unitOfMeasure': 'Percentage of AUCex', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Terminal Phase Half-life (T1/2) for Cefixime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.18', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '3.13', 'spread': '14.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period', 'description': 'Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Non-serious AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 16 in each treatment period', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'ALT; Period 1; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '16.6', 'spread': '10.23', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '5.67', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '13.6', 'spread': '7.09', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '5.76', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Period 2; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '16.4', 'spread': '8.98', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '9.15', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '14.1', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '7.68', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Period 1; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '80.4', 'spread': '12.85', 'groupId': 'OG000'}, {'value': '74.8', 'spread': '18.25', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '75.5', 'spread': '14.27', 'groupId': 'OG000'}, {'value': '67.1', 'spread': '15.23', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Period 2; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '72.4', 'spread': '17.58', 'groupId': 'OG000'}, {'value': '80.9', 'spread': '15.81', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '69.7', 'spread': '16.96', 'groupId': 'OG000'}, {'value': '76.9', 'spread': '15.13', 'groupId': 'OG001'}]}]}, {'title': 'AST; Period 1; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '20.9', 'spread': '4.40', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '4.22', 'groupId': 'OG001'}]}]}, {'title': 'AST; Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '16.7', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '3.45', 'groupId': 'OG001'}]}]}, {'title': 'AST; Period 2; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '20.5', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '19.9', 'spread': '4.57', 'groupId': 'OG001'}]}]}, {'title': 'AST; Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '16.8', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '4.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, ALP and AST.', 'unitOfMeasure': 'Units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Blood Urea Nitrogen (BUN) at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Period 1; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '10.354', 'spread': '1.972', 'groupId': 'OG000'}, {'value': '10.300', 'spread': '4.120', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '12.945', 'spread': '2.349', 'groupId': 'OG000'}, {'value': '12.258', 'spread': '2.664', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '10.841', 'spread': '3.571', 'groupId': 'OG000'}, {'value': '11.844', 'spread': '2.017', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '12.041', 'spread': '2.166', 'groupId': 'OG000'}, {'value': '12.796', 'spread': '1.599', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN.', 'unitOfMeasure': 'Milligrams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Calcium, Glucose, Potassium and Sodium at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Calcium;Period 1;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '2.393', 'spread': '0.059', 'groupId': 'OG000'}, {'value': '2.399', 'spread': '0.134', 'groupId': 'OG001'}]}]}, {'title': 'Calcium;Period 1;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '2.308', 'spread': '0.068', 'groupId': 'OG000'}, {'value': '2.304', 'spread': '0.076', 'groupId': 'OG001'}]}]}, {'title': 'Calcium;Period 2;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '2.364', 'spread': '0.099', 'groupId': 'OG000'}, {'value': '2.376', 'spread': '0.060', 'groupId': 'OG001'}]}]}, {'title': 'Calcium;Period 2;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '2.351', 'spread': '0.087', 'groupId': 'OG000'}, {'value': '2.378', 'spread': '0.081', 'groupId': 'OG001'}]}]}, {'title': 'Glucose;Period 1;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '4.684', 'spread': '0.256', 'groupId': 'OG000'}, {'value': '4.616', 'spread': '0.267', 'groupId': 'OG001'}]}]}, {'title': 'Glucose;Period 1;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '4.728', 'spread': '0.229', 'groupId': 'OG000'}, {'value': '4.676', 'spread': '0.295', 'groupId': 'OG001'}]}]}, {'title': 'Glucose;Period 2;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '4.521', 'spread': '0.347', 'groupId': 'OG000'}, {'value': '4.571', 'spread': '0.404', 'groupId': 'OG001'}]}]}, {'title': 'Glucose;Period 2;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '4.851', 'spread': '0.375', 'groupId': 'OG000'}, {'value': '4.812', 'spread': '0.278', 'groupId': 'OG001'}]}]}, {'title': 'Sodium;Period 1;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '143.86', 'spread': '1.460', 'groupId': 'OG000'}, {'value': '145.00', 'spread': '1.414', 'groupId': 'OG001'}]}]}, {'title': 'Sodium;Period 1;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '141.07', 'spread': '1.439', 'groupId': 'OG000'}, {'value': '141.43', 'spread': '1.604', 'groupId': 'OG001'}]}]}, {'title': 'Sodium;Period 2;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '141.21', 'spread': '1.251', 'groupId': 'OG000'}, {'value': '141.50', 'spread': '1.912', 'groupId': 'OG001'}]}]}, {'title': 'Sodium;Period 2;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '139.43', 'spread': '1.089', 'groupId': 'OG000'}, {'value': '139.64', 'spread': '1.550', 'groupId': 'OG001'}]}]}, {'title': 'Potassium;Period1;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '4.634', 'spread': '0.457', 'groupId': 'OG000'}, {'value': '4.404', 'spread': '0.316', 'groupId': 'OG001'}]}]}, {'title': 'Potassium;Period1;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '4.522', 'spread': '0.444', 'groupId': 'OG000'}, {'value': '4.286', 'spread': '0.206', 'groupId': 'OG001'}]}]}, {'title': 'Potassium;Period 2;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '4.371', 'spread': '0.220', 'groupId': 'OG000'}, {'value': '4.521', 'spread': '0.346', 'groupId': 'OG001'}]}]}, {'title': 'Potassium;Period 2;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '4.269', 'spread': '0.334', 'groupId': 'OG000'}, {'value': '4.555', 'spread': '0.402', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, glucose, potassium and sodium.', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Creat; Period 1; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '82.4', 'spread': '15.29', 'groupId': 'OG000'}, {'value': '83.4', 'spread': '15.45', 'groupId': 'OG001'}]}]}, {'title': 'Creat; Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '79.9', 'spread': '12.00', 'groupId': 'OG000'}, {'value': '85.9', 'spread': '15.59', 'groupId': 'OG001'}]}]}, {'title': 'Creat; Period 2; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '81.1', 'spread': '14.31', 'groupId': 'OG000'}, {'value': '78.5', 'spread': '14.21', 'groupId': 'OG001'}]}]}, {'title': 'Creat; Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '83.9', 'spread': '15.33', 'groupId': 'OG000'}, {'value': '78.4', 'spread': '12.71', 'groupId': 'OG001'}]}]}, {'title': 'Total bil; Period1;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '10.14', 'spread': '4.633', 'groupId': 'OG000'}, {'value': '10.99', 'spread': '6.235', 'groupId': 'OG001'}]}]}, {'title': 'Total bil; Period1;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '6.83', 'spread': '3.004', 'groupId': 'OG000'}, {'value': '8.10', 'spread': '6.191', 'groupId': 'OG001'}]}]}, {'title': 'Total bil; Period2;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '9.90', 'spread': '7.205', 'groupId': 'OG000'}, {'value': '8.22', 'spread': '3.516', 'groupId': 'OG001'}]}]}, {'title': 'Total bil; Period2;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '6.47', 'spread': '3.749', 'groupId': 'OG000'}, {'value': '6.16', 'spread': '2.843', 'groupId': 'OG001'}]}]}, {'title': 'Direct bil; Period1;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '3.68', 'spread': '1.294', 'groupId': 'OG000'}, {'value': '4.01', 'spread': '1.794', 'groupId': 'OG001'}]}]}, {'title': 'Direct bil; Period1;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '2.65', 'spread': '0.959', 'groupId': 'OG000'}, {'value': '2.93', 'spread': '1.630', 'groupId': 'OG001'}]}]}, {'title': 'Direct bil; Period2;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '3.58', 'spread': '1.945', 'groupId': 'OG000'}, {'value': '3.12', 'spread': '1.057', 'groupId': 'OG001'}]}]}, {'title': 'Direct bil; Period2;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '2.55', 'spread': '1.149', 'groupId': 'OG000'}, {'value': '2.49', 'spread': '0.972', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat.', 'unitOfMeasure': 'Micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Total Protein at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Period 1; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '74.34', 'spread': '3.354', 'groupId': 'OG000'}, {'value': '74.77', 'spread': '4.725', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '67.90', 'spread': '3.295', 'groupId': 'OG000'}, {'value': '67.97', 'spread': '2.635', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '73.76', 'spread': '3.995', 'groupId': 'OG000'}, {'value': '72.57', 'spread': '3.886', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '67.64', 'spread': '3.181', 'groupId': 'OG000'}, {'value': '67.89', 'spread': '4.211', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Basophil; Period 1;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '0.023', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.022', 'spread': '0.013', 'groupId': 'OG001'}]}]}, {'title': 'Basophil; Period 1;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '0.025', 'spread': '0.011', 'groupId': 'OG001'}]}]}, {'title': 'Basophil; Period 2;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '0.026', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '0.029', 'spread': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Basophil; Period 2;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '0.022', 'spread': '0.026', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophil; Period 1;Day-1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '0.136', 'spread': '0.130', 'groupId': 'OG000'}, {'value': '0.182', 'spread': '0.157', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophil; Period 1;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '0.146', 'spread': '0.130', 'groupId': 'OG000'}, {'value': '0.204', 'spread': '0.199', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophil; Period 2; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '0.231', 'spread': '0.230', 'groupId': 'OG000'}, {'value': '0.139', 'spread': '0.144', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophil; Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '0.253', 'spread': '0.245', 'groupId': 'OG000'}, {'value': '0.156', 'spread': '0.182', 'groupId': 'OG001'}]}]}, {'title': 'Leucocyte; Period 1;Day-1,24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '5.458', 'spread': '1.643', 'groupId': 'OG000'}, {'value': '5.752', 'spread': '0.907', 'groupId': 'OG001'}]}]}, {'title': 'Leucocyte; Period 1;Day 2,24 Hours Post-dose', 'categories': [{'measurements': [{'value': '5.369', 'spread': '1.535', 'groupId': 'OG000'}, {'value': '5.394', 'spread': '1.019', 'groupId': 'OG001'}]}]}, {'title': 'Leucocyte; Period 2;Day -1,24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '5.736', 'spread': '1.168', 'groupId': 'OG000'}, {'value': '5.463', 'spread': '1.388', 'groupId': 'OG001'}]}]}, {'title': 'Leucocyte; Period 2;Day 2,24 Hours Post-dose', 'categories': [{'measurements': [{'value': '5.887', 'spread': '1.216', 'groupId': 'OG000'}, {'value': '5.477', 'spread': '1.571', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte; Period 1;Day -1,24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '2.127', 'spread': '0.562', 'groupId': 'OG000'}, {'value': '2.154', 'spread': '0.493', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte; Period 1;Day 2,24 Hours Post-dose', 'categories': [{'measurements': [{'value': '1.916', 'spread': '0.453', 'groupId': 'OG000'}, {'value': '2.039', 'spread': '0.459', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte; Period 2;Day -1,24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '2.328', 'spread': '0.573', 'groupId': 'OG000'}, {'value': '2.141', 'spread': '0.409', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte; Period 2;Day 2,24 Hours Post-dose', 'categories': [{'measurements': [{'value': '2.186', 'spread': '0.431', 'groupId': 'OG000'}, {'value': '1.956', 'spread': '0.486', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Period 1;Day -1,24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '0.480', 'spread': '0.123', 'groupId': 'OG000'}, {'value': '0.470', 'spread': '0.127', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Period 1;Day 2,24 Hours Post-dose', 'categories': [{'measurements': [{'value': '0.464', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '0.459', 'spread': '0.125', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Period 2;Day -1,24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '0.461', 'spread': '0.146', 'groupId': 'OG000'}, {'value': '0.497', 'spread': '0.126', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Period 2;Day 2,24 Hours Post-dose', 'categories': [{'measurements': [{'value': '0.475', 'spread': '0.160', 'groupId': 'OG000'}, {'value': '0.457', 'spread': '0.122', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils;Period 1;Day -1,24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '2.692', 'spread': '1.293', 'groupId': 'OG000'}, {'value': '2.924', 'spread': '0.706', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils;Period 1;Day 2,24 Hours Post-dose', 'categories': [{'measurements': [{'value': '2.820', 'spread': '1.289', 'groupId': 'OG000'}, {'value': '2.667', 'spread': '0.667', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils;Period 2;Day -1,24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '2.691', 'spread': '0.697', 'groupId': 'OG000'}, {'value': '2.657', 'spread': '1.162', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils;Period 2;Day 2,24 Hours Post-dose', 'categories': [{'measurements': [{'value': '2.949', 'spread': '0.848', 'groupId': 'OG000'}, {'value': '2.885', 'spread': '1.204', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Period 1;Day -1,24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '288.9', 'spread': '61.98', 'groupId': 'OG000'}, {'value': '264.4', 'spread': '60.63', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Period 1;Day 2,24 Hours Post-dose', 'categories': [{'measurements': [{'value': '281.2', 'spread': '65.74', 'groupId': 'OG000'}, {'value': '244.5', 'spread': '64.60', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Period 2;Day -1,24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '264.6', 'spread': '61.65', 'groupId': 'OG000'}, {'value': '289.6', 'spread': '72.29', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Period 2;Day 2,24 Hours Post-dose', 'categories': [{'measurements': [{'value': '245.0', 'spread': '56.04', 'groupId': 'OG000'}, {'value': '274.2', 'spread': '68.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils.', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Corpuscular Volume (MCV) at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Period 1; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '85.73', 'spread': '2.834', 'groupId': 'OG000'}, {'value': '84.86', 'spread': '4.946', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '85.30', 'spread': '2.796', 'groupId': 'OG000'}, {'value': '84.50', 'spread': '4.895', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '84.83', 'spread': '4.975', 'groupId': 'OG000'}, {'value': '85.97', 'spread': '2.903', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '84.46', 'spread': '4.878', 'groupId': 'OG000'}, {'value': '85.41', 'spread': '2.847', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV.', 'unitOfMeasure': 'Femtoliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Period 1; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '29.58', 'spread': '1.212', 'groupId': 'OG000'}, {'value': '29.44', 'spread': '2.140', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '29.75', 'spread': '1.295', 'groupId': 'OG000'}, {'value': '29.51', 'spread': '2.190', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '29.40', 'spread': '2.242', 'groupId': 'OG000'}, {'value': '29.68', 'spread': '1.207', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '29.54', 'spread': '2.112', 'groupId': 'OG000'}, {'value': '29.75', 'spread': '1.320', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH.', 'unitOfMeasure': 'Picogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Erythrocyte Count at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Period 1; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '5.104', 'spread': '0.451', 'groupId': 'OG000'}, {'value': '5.020', 'spread': '0.480', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '4.952', 'spread': '0.387', 'groupId': 'OG000'}, {'value': '4.871', 'spread': '0.424', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '5.006', 'spread': '0.366', 'groupId': 'OG000'}, {'value': '4.971', 'spread': '0.473', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '4.838', 'spread': '0.433', 'groupId': 'OG000'}, {'value': '4.906', 'spread': '0.494', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count.', 'unitOfMeasure': '10^12 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Hematocrit at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Period 1; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '0.437', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '0.426', 'spread': '0.043', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '0.422', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '0.411', 'spread': '0.038', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '0.424', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.427', 'spread': '0.040', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '0.408', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '0.419', 'spread': '0.041', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit.', 'unitOfMeasure': 'Proportion of red blood cells in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed'}, {'type': 'SECONDARY', 'title': 'Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'MCHC; Period 1; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '34.52', 'spread': '1.030', 'groupId': 'OG000'}, {'value': '34.68', 'spread': '0.957', 'groupId': 'OG001'}]}]}, {'title': 'MCHC; Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '34.88', 'spread': '1.084', 'groupId': 'OG000'}, {'value': '34.89', 'spread': '1.100', 'groupId': 'OG001'}]}]}, {'title': 'MCHC; Period 2; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '34.64', 'spread': '1.100', 'groupId': 'OG000'}, {'value': '34.54', 'spread': '0.880', 'groupId': 'OG001'}]}]}, {'title': 'MCHC; Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '34.95', 'spread': '1.097', 'groupId': 'OG000'}, {'value': '34.82', 'spread': '1.062', 'groupId': 'OG001'}]}]}, {'title': 'Hb; Period 1;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '15.11', 'spread': '1.554', 'groupId': 'OG000'}, {'value': '14.79', 'spread': '1.833', 'groupId': 'OG001'}]}]}, {'title': 'Hb; Period 1;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '14.74', 'spread': '1.391', 'groupId': 'OG000'}, {'value': '14.38', 'spread': '1.623', 'groupId': 'OG001'}]}]}, {'title': 'Hb; Period 2;Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '14.70', 'spread': '1.381', 'groupId': 'OG000'}, {'value': '14.76', 'spread': '1.591', 'groupId': 'OG001'}]}]}, {'title': 'Hb; Period 2;Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '14.29', 'spread': '1.578', 'groupId': 'OG000'}, {'value': '14.60', 'spread': '1.708', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb.', 'unitOfMeasure': 'Grams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed'}, {'type': 'SECONDARY', 'title': 'Percent Reticulocytes at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Period 1; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '1.786', 'spread': '0.361', 'groupId': 'OG000'}, {'value': '1.700', 'spread': '0.346', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '1.757', 'spread': '0.384', 'groupId': 'OG000'}, {'value': '1.571', 'spread': '0.297', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day -1, 24 Hours Pre-dose', 'categories': [{'measurements': [{'value': '1.729', 'spread': '0.397', 'groupId': 'OG000'}, {'value': '1.886', 'spread': '0.335', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '2.350', 'spread': '2.176', 'groupId': 'OG000'}, {'value': '1.743', 'spread': '0.361', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes.', 'unitOfMeasure': 'Percentage of reticulocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. PCI ranges for urinalysis parameters were as follows: specific gravity 1.001 to 1.035 kilogram per liter, blood negative (0 to 9) RBC per microliter, pH 4.6 to 8.0, protein negative (0.0 to 0.14) gram per liter, glucose negative (0 to 5.49) millimoles per liter, ketones negative (0.0 to 0.49) millimoles per liter, urobilinogen (0.0 to 1.0) milligrams per deciliter, urine leucocytes negative (0 to 14) leucocytes per microliter, Urine WBC, RBC and epithelial cells 0 to 5 high power per field.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Period 1; Day 1, 1.5 Hours Pre-dose', 'categories': [{'measurements': [{'value': '15.0', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 1, 2 Hours Post-dose', 'categories': [{'measurements': [{'value': '17.3', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '2.69', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 1, 4 Hours Post-dose', 'categories': [{'measurements': [{'value': '15.5', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 1, 6 Hours Post-dose', 'categories': [{'measurements': [{'value': '15.0', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '15.9', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '2.95', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 1, 1.5 Hours Pre-dose', 'categories': [{'measurements': [{'value': '15.8', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 1, 2 Hours Post-dose', 'categories': [{'measurements': [{'value': '18.4', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '1.72', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 1, 4 Hours Post-dose', 'categories': [{'measurements': [{'value': '16.7', 'spread': '3.10', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '1.65', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 1, 6 Hours Post-dose', 'categories': [{'measurements': [{'value': '17.9', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '16.2', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '2.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period', 'description': 'Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.', 'unitOfMeasure': 'Breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Pulse Rate at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Period 1; Day 1, 1.5 Hours Pre-dose', 'categories': [{'measurements': [{'value': '67.0', 'spread': '7.95', 'groupId': 'OG000'}, {'value': '58.1', 'spread': '8.76', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 1, 2 Hours Post-dose', 'categories': [{'measurements': [{'value': '61.0', 'spread': '8.17', 'groupId': 'OG000'}, {'value': '55.1', 'spread': '8.32', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 1, 4 Hours Post-dose', 'categories': [{'measurements': [{'value': '61.9', 'spread': '7.44', 'groupId': 'OG000'}, {'value': '55.6', 'spread': '7.49', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 1, 6 Hours Post-dose', 'categories': [{'measurements': [{'value': '75.0', 'spread': '8.74', 'groupId': 'OG000'}, {'value': '67.2', 'spread': '12.97', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '66.5', 'spread': '10.26', 'groupId': 'OG000'}, {'value': '54.3', 'spread': '7.22', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 1, 1.5 Hours Pre-dose', 'categories': [{'measurements': [{'value': '57.9', 'spread': '9.08', 'groupId': 'OG000'}, {'value': '65.1', 'spread': '6.85', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 1, 2 Hours Post-dose', 'categories': [{'measurements': [{'value': '54.1', 'spread': '8.88', 'groupId': 'OG000'}, {'value': '63.1', 'spread': '8.87', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 1, 4 Hours Post-dose', 'categories': [{'measurements': [{'value': '56.6', 'spread': '8.67', 'groupId': 'OG000'}, {'value': '62.8', 'spread': '7.92', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 1, 6 Hours Post-dose', 'categories': [{'measurements': [{'value': '68.5', 'spread': '14.09', 'groupId': 'OG000'}, {'value': '75.1', 'spread': '8.82', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '59.2', 'spread': '7.59', 'groupId': 'OG000'}, {'value': '67.1', 'spread': '8.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period', 'description': 'Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Body Temperature at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'Period 1; Day 1, 1.5 Hours Pre-dose', 'categories': [{'measurements': [{'value': '36.19', 'spread': '0.305', 'groupId': 'OG000'}, {'value': '36.27', 'spread': '0.336', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 1, 2 Hours Post-dose', 'categories': [{'measurements': [{'value': '36.38', 'spread': '0.333', 'groupId': 'OG000'}, {'value': '36.23', 'spread': '0.261', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 1, 4 Hours Post-dose', 'categories': [{'measurements': [{'value': '36.48', 'spread': '0.336', 'groupId': 'OG000'}, {'value': '36.59', 'spread': '0.352', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 1, 6 Hours Post-dose', 'categories': [{'measurements': [{'value': '36.64', 'spread': '0.303', 'groupId': 'OG000'}, {'value': '36.79', 'spread': '0.202', 'groupId': 'OG001'}]}]}, {'title': 'Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '36.29', 'spread': '0.317', 'groupId': 'OG000'}, {'value': '36.24', 'spread': '0.365', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 1, 1.5 Hours Pre-dose', 'categories': [{'measurements': [{'value': '36.28', 'spread': '0.372', 'groupId': 'OG000'}, {'value': '36.29', 'spread': '0.317', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 1, 2 Hours Post-dose', 'categories': [{'measurements': [{'value': '36.51', 'spread': '0.400', 'groupId': 'OG000'}, {'value': '36.42', 'spread': '0.404', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 1, 4 Hours Post-dose', 'categories': [{'measurements': [{'value': '36.58', 'spread': '0.347', 'groupId': 'OG000'}, {'value': '36.51', 'spread': '0.243', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 1, 6 Hours Post-dose', 'categories': [{'measurements': [{'value': '36.10', 'spread': '0.421', 'groupId': 'OG000'}, {'value': '36.63', 'spread': '0.300', 'groupId': 'OG001'}]}]}, {'title': 'Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '36.30', 'spread': '0.321', 'groupId': 'OG000'}, {'value': '36.11', 'spread': '0.434', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period', 'description': 'Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.', 'unitOfMeasure': 'Degree Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SKF101804 Cefixime', 'description': 'Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}, {'id': 'OG001', 'title': 'Cefixime Reference Formulation', 'description': 'Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'classes': [{'title': 'SBP, Period 1; Day 1, 1.5 Hours Pre-dose', 'categories': [{'measurements': [{'value': '110.6', 'spread': '8.22', 'groupId': 'OG000'}, {'value': '110.9', 'spread': '6.39', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Period 1; Day 1, 2 Hours Post-dose', 'categories': [{'measurements': [{'value': '113.4', 'spread': '7.30', 'groupId': 'OG000'}, {'value': '111.3', 'spread': '8.68', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Period 1; Day 1, 4 Hours Post-dose', 'categories': [{'measurements': [{'value': '112.3', 'spread': '8.39', 'groupId': 'OG000'}, {'value': '112.1', 'spread': '4.25', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Period 1; Day 1, 6 Hours Post-dose', 'categories': [{'measurements': [{'value': '111.6', 'spread': '7.17', 'groupId': 'OG000'}, {'value': '108.6', 'spread': '6.46', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '110.9', 'spread': '6.86', 'groupId': 'OG000'}, {'value': '115.4', 'spread': '7.00', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Period 2; Day 1, 1.5 Hours Pre-dose', 'categories': [{'measurements': [{'value': '110.4', 'spread': '3.97', 'groupId': 'OG000'}, {'value': '111.2', 'spread': '10.09', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Period 2; Day 1, 2 Hours Post-dose', 'categories': [{'measurements': [{'value': '113.1', 'spread': '6.24', 'groupId': 'OG000'}, {'value': '112.7', 'spread': '10.94', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Period 2; Day 1, 4 Hours Post-dose', 'categories': [{'measurements': [{'value': '112.6', 'spread': '8.53', 'groupId': 'OG000'}, {'value': '111.1', 'spread': '9.79', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Period 2; Day 1, 6 Hours Post-dose', 'categories': [{'measurements': [{'value': '109.6', 'spread': '7.14', 'groupId': 'OG000'}, {'value': '109.5', 'spread': '8.98', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '113.1', 'spread': '6.24', 'groupId': 'OG000'}, {'value': '113.6', 'spread': '9.05', 'groupId': 'OG001'}]}]}, {'title': 'DBP, Period 1; Day 1, 1.5 Hours Pre-dose', 'categories': [{'measurements': [{'value': '62.9', 'spread': '6.59', 'groupId': 'OG000'}, {'value': '64.1', 'spread': '7.76', 'groupId': 'OG001'}]}]}, {'title': 'DBP, Period 1; Day 1, 2 Hours Post-dose', 'categories': [{'measurements': [{'value': '62.9', 'spread': '7.69', 'groupId': 'OG000'}, {'value': '60.9', 'spread': '6.38', 'groupId': 'OG001'}]}]}, {'title': 'DBP, Period 1; Day 1, 4 Hours Post-dose', 'categories': [{'measurements': [{'value': '62.5', 'spread': '5.43', 'groupId': 'OG000'}, {'value': '63.3', 'spread': '6.94', 'groupId': 'OG001'}]}]}, {'title': 'DBP, Period 1; Day 1, 6 Hours Post-dose', 'categories': [{'measurements': [{'value': '59.3', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '59.6', 'spread': '5.09', 'groupId': 'OG001'}]}]}, {'title': 'DBP, Period 1; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '63.0', 'spread': '6.80', 'groupId': 'OG000'}, {'value': '66.2', 'spread': '7.65', 'groupId': 'OG001'}]}]}, {'title': 'DBP, Period 2; Day 1, 1.5 Hours Pre-dose', 'categories': [{'measurements': [{'value': '111.2', 'spread': '10.09', 'groupId': 'OG000'}, {'value': '61.8', 'spread': '7.20', 'groupId': 'OG001'}]}]}, {'title': 'DBP, Period 2; Day 1, 2 Hours Post-dose', 'categories': [{'measurements': [{'value': '66.2', 'spread': '7.65', 'groupId': 'OG000'}, {'value': '63.1', 'spread': '9.12', 'groupId': 'OG001'}]}]}, {'title': 'DBP, Period 2; Day 1, 4 Hours Post-dose', 'categories': [{'measurements': [{'value': '63.5', 'spread': '8.55', 'groupId': 'OG000'}, {'value': '62.6', 'spread': '8.21', 'groupId': 'OG001'}]}]}, {'title': 'DBP, Period 2; Day 1, 6 Hours Post-dose', 'categories': [{'measurements': [{'value': '59.4', 'spread': '4.97', 'groupId': 'OG000'}, {'value': '60.2', 'spread': '7.79', 'groupId': 'OG001'}]}]}, {'title': 'DBP, Period 2; Day 2, 24 Hours Post-dose', 'categories': [{'measurements': [{'value': '63.9', 'spread': '7.41', 'groupId': 'OG000'}, {'value': '67.7', 'spread': '7.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period', 'description': 'Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.', 'unitOfMeasure': 'Millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time points were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SKF101804 Cefixime Followed by Cefixime Reference Formulation', 'description': 'Eligible participants received single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) orally on Day 1 in Treatment period 1. It was followed by a washout period of at least 7 days and not more than 14 days. Participants received single dose of Reference formulation (cefixime 200 mg/5 mL suspension) orally on Day 1 in Treatment period 2.'}, {'id': 'FG001', 'title': 'Cefixime Reference Formulation Followed by SKF101804 Cefixime', 'description': 'Eligible participants received single dose of Reference formulation (cefixime 200 mg/5 mL suspension) orally on Day 1 in Treatment period 1. It was followed by a washout period of at least 7 days and not more than 14 days. Participants received single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) orally on Day 1 in Treatment period 2.'}], 'periods': [{'title': 'Treatment Period 1 (16 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Wash-out Period (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (16 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was an open-label, randomized, single-dose, two-period cross-over study to evaluate bioequivalence of SKF101804 Cefixime 200 milligram (mg)/5 milliliter (mL) suspension versus Cefixime 200 mg/5 mL suspension reference product in healthy adult participants under fasting conditions. Participants were enrolled at a single center in South Africa.', 'preAssignmentDetails': 'Participants received treatment in one of the two sequences; SKF101804 cefixime 200mg/5mL suspension (Test formulation) followed by cefixime 200mg/5mL suspension (Reference formulation)or vice versa in each of the treatment period 1 and 2. A total number of 28 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Eligible participants received a single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) followed by Reference formulation (cefixime 200 mg/5 mL suspension) or vice versa, administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '7.90', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Mixed Race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White/Caucasian/European Heritage', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-13', 'size': 676796, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-12T06:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-17', 'studyFirstSubmitDate': '2018-01-17', 'resultsFirstSubmitDate': '2018-12-11', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-11', 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime', 'timeFrame': 'Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period', 'description': 'Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime', 'timeFrame': 'Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period', 'description': 'Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime', 'timeFrame': 'Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period', 'description': 'Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.'}, {'measure': 'Time of Occurrence of Cmax (Tmax) for Cefixime', 'timeFrame': 'Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period', 'description': 'Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of cefixime was analyzed using a nonparametric test to compute point estimate of the median and full range.'}, {'measure': 'Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime', 'timeFrame': 'Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period', 'description': 'Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.'}, {'measure': 'Terminal Phase Half-life (T1/2) for Cefixime', 'timeFrame': 'Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period', 'description': 'Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.'}, {'measure': 'Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)', 'timeFrame': 'Up to Day 16 in each treatment period', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.'}, {'measure': 'Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, ALP and AST.'}, {'measure': 'Blood Urea Nitrogen (BUN) at Indicated Time-points', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN.'}, {'measure': 'Calcium, Glucose, Potassium and Sodium at Indicated Time-points', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, glucose, potassium and sodium.'}, {'measure': 'Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat.'}, {'measure': 'Total Protein at Indicated Time-points', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein.'}, {'measure': 'Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils.'}, {'measure': 'Mean Corpuscular Volume (MCV) at Indicated Time-points', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV.'}, {'measure': 'Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH.'}, {'measure': 'Erythrocyte Count at Indicated Time-points', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count.'}, {'measure': 'Hematocrit at Indicated Time-points', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit.'}, {'measure': 'Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb.'}, {'measure': 'Percent Reticulocytes at Indicated Time-points', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes.'}, {'measure': 'Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis', 'timeFrame': 'Day -1 and Day 2 of each treatment period', 'description': 'Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. PCI ranges for urinalysis parameters were as follows: specific gravity 1.001 to 1.035 kilogram per liter, blood negative (0 to 9) RBC per microliter, pH 4.6 to 8.0, protein negative (0.0 to 0.14) gram per liter, glucose negative (0 to 5.49) millimoles per liter, ketones negative (0.0 to 0.49) millimoles per liter, urobilinogen (0.0 to 1.0) milligrams per deciliter, urine leucocytes negative (0 to 14) leucocytes per microliter, Urine WBC, RBC and epithelial cells 0 to 5 high power per field.'}, {'measure': 'Respiratory Rate at Indicated Time-points', 'timeFrame': 'Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period', 'description': 'Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.'}, {'measure': 'Pulse Rate at Indicated Time-points', 'timeFrame': 'Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period', 'description': 'Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.'}, {'measure': 'Body Temperature at Indicated Time-points', 'timeFrame': 'Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period', 'description': 'Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.'}, {'measure': 'Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points', 'timeFrame': 'Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period', 'description': 'Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Single dose', 'Oral suspension', 'Bioequivalence', 'Cefixime', 'Two-way crossover'], 'conditions': ['Infections, Bacterial']}, 'descriptionModule': {'briefSummary': 'This study is open-label, randomized two-way cross-over study to determine if cefixime 200 mg/5 mL powder for suspension (test formulation: SKF101804) is bioequivalent to cefixime 200 mg/5 mL suspension reference formulation. Study will be conducted in 28 healthy adult subjects under fasting conditions. There will be two treatment periods and each subject will participate in both periods. The washout period between both treatment periods will be 7-14 days. Subjects will be randomized to either of treatment sequences of reference followed by test or test followed by reference to receive a single dose of test or reference formulation on Day 1 in each treatment period. The study will last for 5 to 7 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must be 18 to 65 years of age inclusive, at the time of signing the informed consent.\n* Subject must be healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n* A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the normal reference range for the population being studied may be included at investigator discretion in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.\n* Subject with a body weight 50 kilogram (kg) and body mass index (BMI) within the range 19-30 kilogram per meter square (kg/m\\^2) (inclusive).\n* A healthy male subject must agree to use contraception during the treatment period and for at least 5 days after the last dose of study treatment and refrain from donating sperm during this period.\n* A female subject is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment.\n* A subject should be capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Subject with history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.\n* Subjects with any other condition that is capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.\n* Subject with abnormal renal function, as determined by creatinine clearance and considered as clinically significant by the investigator will be excluded.\n* Subject with abnormal blood pressure (BP) as determined by the investigator.\n* Subject with lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.\n* Subject who had breast cancer within the past 10 years.\n* ALT \\>1.5 times upper limit of normal (ULN).\n* Bilirubin \\>1.5 times ULN (isolated bilirubin \\>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \\<35%).\n* Subject with current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n* Subject with history of colitis\n* Subject with history of cephalosporin induced hemolytic anemia.\n* QT interval corrected for heart rate according to Bazett's formula (QTcB) \\>450 milliseconds (msec). Subjects with a known risk of QT prolongation will be excluded.\n* Past or intended use of over-the-counter or prescription medication including herbal medications, within 14 days prior to dosing unless in the opinion of the investigator and sponsor, the medication will not interfere with the study.\n* Participation in the study would result in loss of blood or blood products in excess of 500 mL within 90 days.\n* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.\n* Current enrolment or past participation within the last 90 days before signing of consent in this or any other clinical study involving an investigational study treatment or any other type of medical research.\n* Presence of Hepatitis B surface antigen (HBsAg) at screening. Positive Hepatitis C antibody test result at screening. Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C ribonucleic acid (RNA) test is obtained.\n* Positive pre-study drug/alcohol screen.\n* Positive human immunodeficiency virus (HIV) antibody test.\n* Regular use of known drugs of abuse.\n* Subjects with regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \\>21 units for males or \\>14 units for females. One unit is equivalent to 8 gram (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.\n* Subjects with urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.\n* Subjects who are sensitive to heparin or heparin-induced thrombocytopenia.\n* Subjects with known sensitivity to any drugs from the class of cephalosporin, or components thereof.\n* Subjects with known sensitivity to any drugs from the class of penicillin, or components thereof.\n* Subjects with known sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study."}, 'identificationModule': {'nctId': 'NCT03408392', 'briefTitle': 'Bioequivalence Study Between SKF101804 Cefixime 200 Milligram (mg)/5 Milliliter (mL) Suspension Versus Cefixime 200 mg/5 mL Suspension Reference Product in Healthy Adult Subjects Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open-label, Randomised, Single-dose, Two-period Cross-over Study to Evaluate Bioequivalence of SKF101804 Cefixime 200 mg/5 mL Suspension Versus Cefixime 200 mg/5 mL Suspension Reference Product in Healthy Adult Participants Under Fasting Conditions', 'orgStudyIdInfo': {'id': '205731'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test followed by Reference Formulation', 'description': 'Subjects will be randomized to receive single dose of Test formulation (SKF101804: cefixime 200 mg/ 5 mL) on Day 1 of the treatment period 1 and Reference formulation (cefixime 200 mg/5 mL) on Day 1 of the treatment period 2. There will be wash out period of 7-14 days between the two treatment periods.', 'interventionNames': ['Drug: Test formulation A', 'Drug: Reference formulation B']}, {'type': 'EXPERIMENTAL', 'label': 'Reference followed by Test Formulation', 'description': 'Subjects will be randomized to receive single dose of Reference formulation (cefixime 200 mg/5 mL) on Day 1 of the treatment period 1 and Test formulation (SKF101804: cefixime 200 mg/ 5 mL) on Day 1 of the treatment period 2. There will be wash out period of 7-14 days between the two treatment periods.', 'interventionNames': ['Drug: Test formulation A', 'Drug: Reference formulation B']}], 'interventions': [{'name': 'Test formulation A', 'type': 'DRUG', 'description': 'Test formulation: SKF101804 will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a fruit flavor and odor.', 'armGroupLabels': ['Reference followed by Test Formulation', 'Test followed by Reference Formulation']}, {'name': 'Reference formulation B', 'type': 'DRUG', 'description': 'Reference formulation will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a strawberry flavor and odor.', 'armGroupLabels': ['Reference followed by Test Formulation', 'Test followed by Reference Formulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Bloemfontein', 'state': 'Free State', 'country': 'South Africa', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/Posting.aspx?ID=20173', 'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}