Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT02605395
Status:
COMPLETED
Last Update Posted:
2018-10-01
First Post:
2015-05-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064750', 'term': 'Rabeprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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': 'From start of study treatment up to end of the follow-up (24 hours post last blood sample collected for Period 2; Up to 10 days)', 'description': 'All subject population was used for analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Idiazole 20 mg', 'description': 'Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pariet 20 mg', 'description': 'Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximal Measured Plasma Concentration (Cmax) of Rabeprazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiazole 20 mg', 'description': 'Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.'}, {'id': 'OG001', 'title': 'Pariet 20 mg', 'description': 'Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '393.50', 'spread': '158.60', 'groupId': 'OG000'}, {'value': '415.83', 'spread': '179.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.71', 'ciLowerLimit': '90.12', 'ciUpperLimit': '101.65', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for Cmax to be within 80-125% to prove equivalency.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2', 'description': 'Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. The Cmax was computed directly from measured data.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population comprised of all participants who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC [0-t]) of Rabeprazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiazole 20 mg', 'description': 'Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.'}, {'id': 'OG001', 'title': 'Pariet 20 mg', 'description': 'Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '812.30', 'spread': '461.30', 'groupId': 'OG000'}, {'value': '843.68', 'spread': '425.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.50', 'ciLowerLimit': '90.02', 'ciUpperLimit': '103.44', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC(0-t) to be within 80-125% to prove equivalency.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2', 'description': 'Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. AUC (0-t) was calculated from measured data points from time of administration to time of last quantifiable concentration (Clast) by the linear trapezoidal rule.', 'unitOfMeasure': 'Hour*nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population.'}, {'type': 'PRIMARY', 'title': 'Mean Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC [0 to Infinity]) of Rabeprazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiazole 20 mg', 'description': 'Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.'}, {'id': 'OG001', 'title': 'Pariet 20 mg', 'description': 'Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '798.59', 'spread': '314.16', 'groupId': 'OG000'}, {'value': '931.81', 'spread': '442.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.69', 'ciLowerLimit': '87.06', 'ciUpperLimit': '105.17', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC (0 to infinity) to be within 80-125% to prove equivalency.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2', 'description': 'Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods.', 'unitOfMeasure': 'Hour*nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population.'}, {'type': 'SECONDARY', 'title': 'Mean Time to the Maximum Plasma Concentration (Tmax) of Rabeprazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiazole 20 mg', 'description': 'Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.'}, {'id': 'OG001', 'title': 'Pariet 20 mg', 'description': 'Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.93', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '3.86', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2', 'description': 'Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. Tmax was computed directly from the measured data.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population.'}, {'type': 'SECONDARY', 'title': 'Mean Apparent First-order Elimination or Terminal Rate Constant (Ke) of Rabeprazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiazole 20 mg', 'description': 'Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.'}, {'id': 'OG001', 'title': 'Pariet 20 mg', 'description': 'Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2', 'description': 'Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. Ke was derived from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.', 'unitOfMeasure': 'Per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population'}, {'type': 'SECONDARY', 'title': 'Mean Terminal Half Life (t1/2) of Rabeprazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiazole 20 mg', 'description': 'Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.'}, {'id': 'OG001', 'title': 'Pariet 20 mg', 'description': 'Eligible participants received a single dose of Pariet 20 mg gastro-resistant tablets under fed condition in treatment period 1 or 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.49', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '5.81', 'spread': '3.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2', 'description': 'Half life is the period of time required for the concentration or amount of drug in the body to be reduced by one-half. Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. t1/2 was calculated as: t1/2 = Ln(2) / (-b), where b was obtained as the slope of the linear regression of the Ln-transformed plasma concentrations versus time in the terminal period of the plasma curve.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pariet 20 mg Followed by Idiazole 20 mg', 'description': 'Eligible participants received a single oral dose of Pariet 20 mg enteric coated tablet in period 1 followed by Idiazole 20 mg gastro-resistant tablets in period 2. Both the treatments were administered under fed condition. Treatment period 1 and period 2 were separated by a 7 days washout period.'}, {'id': 'FG001', 'title': 'Idiazole 20 mg Followed by Pariet 20 mg', 'description': 'Eligible participants received a single oral dose of Idiazole 20 mg gastro-resistant tablets in period 1 followed by Pariet 20 mg enteric coated tablet in period 2. Both the treatments were administered under fed condition. Treatment period 1 and period 2 were separated by a 7 days washout period.'}], 'periods': [{'title': 'Period 1, Day 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period, Day 2 to Day 7', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2, Day 8', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Bioequivalence of rabeprazole from Idiazole 20 milligram (mg) tablets and Pariet 20 mg tablets was investigated after single oral dose administration to healthy participants under fed conditions. This study was conducted from 22 March 2014 to 30 March 2014.', 'preAssignmentDetails': 'During this study, 74 participants were screened. One participant was excluded for significant variation in laboratory results at screening and three participants voluntarily withdrew before entering in to period 1. Hence, 70 participants were enrolled and randomized in study, and all 70 participants completed both periods of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Eligible participants received a single oral dose of Pariet 20 mg enteric coated tablets or Idiazole 20 mg gastro-resistant tablets under fed condition in any of the 2 treatment periods. There was a 7 days washout interval between two study drug administration.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.76', 'spread': '9.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Egypt', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2014-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-31', 'studyFirstSubmitDate': '2015-05-14', 'resultsFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2015-11-12', 'lastUpdatePostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-31', 'studyFirstPostDateStruct': {'date': '2015-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal Measured Plasma Concentration (Cmax) of Rabeprazole', 'timeFrame': 'Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2', 'description': 'Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. The Cmax was computed directly from measured data.'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC [0-t]) of Rabeprazole', 'timeFrame': 'Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2', 'description': 'Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. AUC (0-t) was calculated from measured data points from time of administration to time of last quantifiable concentration (Clast) by the linear trapezoidal rule.'}, {'measure': 'Mean Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC [0 to Infinity]) of Rabeprazole', 'timeFrame': 'Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2', 'description': 'Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods.'}], 'secondaryOutcomes': [{'measure': 'Mean Time to the Maximum Plasma Concentration (Tmax) of Rabeprazole', 'timeFrame': 'Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2', 'description': 'Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. Tmax was computed directly from the measured data.'}, {'measure': 'Mean Apparent First-order Elimination or Terminal Rate Constant (Ke) of Rabeprazole', 'timeFrame': 'Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2', 'description': 'Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. Ke was derived from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.'}, {'measure': 'Mean Terminal Half Life (t1/2) of Rabeprazole', 'timeFrame': 'Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2', 'description': 'Half life is the period of time required for the concentration or amount of drug in the body to be reduced by one-half. Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. t1/2 was calculated as: t1/2 = Ln(2) / (-b), where b was obtained as the slope of the linear regression of the Ln-transformed plasma concentrations versus time in the terminal period of the plasma curve.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Fed condition', 'PARIET 20 mg', 'IDIAZOLE 20mg', 'Rabeprazole'], 'conditions': ['Gastrointestinal Diseases']}, 'referencesModule': {'availIpds': [{'id': '201528', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '201528', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '201528', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '201528', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, randomized, single dose, two-sequence, two-periods crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each to healthy adults fed under conditions.\n\nIn Period 1, subjects will be randomized to either Idiazole 20mg DR tabs or PARIET 20 mg DR tabs. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.\n\nPARIET is a registered trademark of EISAI Co. Limited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female, age 18 to 55 years, inclusive.\n* Body weight within 10 percent of normal range according to the accepted normal values for body mass index (BMI).\n* Medical demographics without evidence of clinically significant deviation from normal medical condition.\n* Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.\n* Subject does not have allergy to the drugs under investigation.\n\nExclusion Criteria:\n\n* Subjects with known allergy to the products tested.\n* Subjects whose values of BMI were outside the accepted normal ranges.\n* Female subjects who were pregnant, nursing or taking birth control pills.\n* Medical demographics with evidence of clinically significant deviation from normal medical condition.\n* Results of laboratory tests which are clinically significant.\n* Acute infection within one week preceding first study drug administration.\n* History of drug or alcohol abuse.\n* Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.\n* Subject is on a special diet (for example subject is vegetarian).\n* Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.\n* Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.\n* Subject has a history of severe diseases which have direct impact on the study.\n* Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.\n* Subject intends to be hospitalized within 6 weeks after first study drug administration.\n* Subjects who, through completion of this study, would have donated more than 500 milliliter (mL) of blood in 7 days, or 750 mL of blood in 30 days, 1000 mL in 90 days, 1250 mL in 120 days, 1500 ml in 180 days, 2000 mL in 270 days, 2500 mL of blood in 1 year.'}, 'identificationModule': {'nctId': 'NCT02605395', 'briefTitle': 'Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Comparative Randomized, Single Dose, Two-way Crossover Open-label Study to Determine the Bioequivalence of Rabeprazole From Raperazole 20mg DR Tabs (GSK, Egypt) and PARIET 20 mg DR Tabs (JANSSEN, EGYPT) After a Single Oral Dose Administration of Each to Healthy Adults Under Fed Conditions', 'orgStudyIdInfo': {'id': '201528'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A-Idiazole then Pariet', 'description': 'Subjects will receive a single oral dose of IDIAZOLE 20mg DR tabs under fed condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of PARIET 20 mg DR tabs under fed condition in treatment period 2.', 'interventionNames': ['Drug: IDIAZOLE 20mg DR tabs', 'Drug: PARIET 20 mg DR tabs']}, {'type': 'EXPERIMENTAL', 'label': 'Group B-Pariet then Idiazole', 'description': 'Subjects will receive a single oral dose of PARIET 20 mg DR tabs under fed condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of Idiazole 20mg DR tabs under fed condition in treatment period 2.', 'interventionNames': ['Drug: IDIAZOLE 20mg DR tabs', 'Drug: PARIET 20 mg DR tabs']}], 'interventions': [{'name': 'IDIAZOLE 20mg DR tabs', 'type': 'DRUG', 'description': 'IDIAZOLE 20mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.', 'armGroupLabels': ['Group A-Idiazole then Pariet', 'Group B-Pariet then Idiazole']}, {'name': 'PARIET 20 mg DR tabs', 'type': 'DRUG', 'description': 'PARIET 20 mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg rabeprazole sodium.', 'armGroupLabels': ['Group A-Idiazole then Pariet', 'Group B-Pariet then Idiazole']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}