Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-26 @ 6:26 PM
Study NCT ID:
NCT00945750
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2009-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)
Sponsor:
Organization:
Raw JSON
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Any information identified by Merck as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 31 days (including 14 day follow-up)', 'eventGroups': [{'id': 'EG000', 'title': 'Famotidine 20 mg FCT With Water', 'description': 'Famotidine 20 mg FCT (film-coated tablet) with 120 mL of water', 'otherNumAtRisk': 30, 'otherNumAffected': 4, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Famotidine 20 mg CT Without Water', 'description': 'Famotidine 20 mg Chewable Tablet without water', 'otherNumAtRisk': 30, 'otherNumAffected': 3, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Famotidine 20 mg CT With Water', 'description': 'Famotidine 20 mg chewable tablet with 120 mL of water', 'otherNumAtRisk': 30, 'otherNumAffected': 4, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Syncope vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-∞) Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Famotidine 20 mg CT Without Water', 'description': 'Famotidine 20 mg CT without water'}, {'id': 'OG001', 'title': 'Famotidine 20 mg FCT With Water', 'description': 'Famotidine 20 mg FCT with 120 mL of water'}], 'classes': [{'categories': [{'measurements': [{'value': '398.5', 'groupId': 'OG000', 'lowerLimit': '350.9', 'upperLimit': '452.6'}, {'value': '394.8', 'groupId': 'OG001', 'lowerLimit': '347.6', 'upperLimit': '448.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciPctValue': '90', 'paramValue': '1.01', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.09', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'If the 90% CI for the AUC geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose', 'description': 'AUC values were natural log-transformed and analyzed using an analysis of variance (ANOVA) model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.', 'unitOfMeasure': 'ng/mL hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'PRIMARY', 'title': 'Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Famotidine 20 mg CT Without Water', 'description': 'Famotidine 20 mg CT without water'}, {'id': 'OG001', 'title': 'Famotidine 20 mg FCT With Water', 'description': 'Famotidine 20 mg FCT with 120 mL of water'}], 'classes': [{'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '76.9'}, {'value': '65.1', 'groupId': 'OG001', 'lowerLimit': '56.9', 'upperLimit': '74.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciPctValue': '90', 'paramValue': '1.03', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'If the 90% CI for the Cmax geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose', 'description': 'Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Famotidine 20 mg CT With Water', 'description': 'Famotidine 20 mg CT with 120 mL of water'}, {'id': 'OG001', 'title': 'Famotidine 20 mg FCT With Water', 'description': 'Famotidine 20 mg FCT with 120 mL of water'}], 'classes': [{'categories': [{'measurements': [{'value': '440.1', 'groupId': 'OG000', 'lowerLimit': '387.5', 'upperLimit': '499.8'}, {'value': '394.8', 'groupId': 'OG001', 'lowerLimit': '347.6', 'upperLimit': '448.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciPctValue': '90', 'paramValue': '1.11', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.20', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose', 'description': 'AUC values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.', 'unitOfMeasure': 'ng/mL hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}, {'type': 'SECONDARY', 'title': 'Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Famotidine 20 mg CT With Water', 'description': 'Famotidine 20 mg CT with 120 mL of water'}, {'id': 'OG001', 'title': 'Famotidine 20 mg FCT With Water', 'description': 'Famotidine 20 mg FCT with 120 mL of water'}], 'classes': [{'categories': [{'measurements': [{'value': '73.0', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '83.6'}, {'value': '65.1', 'groupId': 'OG001', 'lowerLimit': '56.9', 'upperLimit': '74.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciPctValue': '90', 'paramValue': '1.12', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose', 'description': 'Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FCT With Water / CT Without Water / CT With Water', 'description': 'Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.'}, {'id': 'FG001', 'title': 'CT Without Water / CT With Water / FCT With Water', 'description': 'Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.'}, {'id': 'FG002', 'title': 'CT With Water / FCT With Water / CT Without Water', 'description': 'Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.'}, {'id': 'FG003', 'title': 'FCT With Water / CT With Water / CT Without Water', 'description': 'Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.'}, {'id': 'FG004', 'title': 'CT Without Water / FCT With Water / CT With Water', 'description': 'Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.'}, {'id': 'FG005', 'title': 'CT With Water / CT Without Water / FCT With Water', 'description': 'Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.'}], 'periods': [{'title': 'Period I', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period III', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants were randomized to 1 of 6 treatment sequences of 1 of 3 treatments: (1) famotidine as a film-coated tablet (FCT) taken with water, (2) famotidine as a chewable tablet (CTw) taken with water, and (3) famotidine as a chewable tablet taken without water, over 3 study periods in a crossover design.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'FCT With Water / CT Without Water / CT With Water', 'description': 'Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.'}, {'id': 'BG001', 'title': 'CT Without Water / CT With Water / FCT With Water', 'description': 'Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.'}, {'id': 'BG002', 'title': 'CT With Water / FCT With Water / CT Without Water', 'description': 'Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.'}, {'id': 'BG003', 'title': 'FCT With Water / CT With Water / CT Without Water', 'description': 'Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.'}, {'id': 'BG004', 'title': 'CT Without Water / FCT With Water / CT With Water', 'description': 'Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.'}, {'id': 'BG005', 'title': 'CT With Water / CT Without Water / FCT With Water', 'description': 'Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '5.32', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '39'}, {'value': '24.0', 'spread': '7.38', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '36'}, {'value': '24.2', 'spread': '4.38', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '31'}, {'value': '22.6', 'spread': '3.51', 'groupId': 'BG003', 'lowerLimit': '19', 'upperLimit': '28'}, {'value': '26.4', 'spread': '6.11', 'groupId': 'BG004', 'lowerLimit': '19', 'upperLimit': '36'}, {'value': '25.6', 'spread': '6.50', 'groupId': 'BG005', 'lowerLimit': '22', 'upperLimit': '37'}, {'value': '25.9', 'spread': '6.09', 'groupId': 'BG006', 'lowerLimit': '18', 'upperLimit': '39'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '137.6', 'groupId': 'BG000', 'lowerLimit': '106.9', 'upperLimit': '158.4'}, {'value': '163.0', 'groupId': 'BG001', 'lowerLimit': '140.6', 'upperLimit': '187.1'}, {'value': '175.4', 'groupId': 'BG002', 'lowerLimit': '139.6', 'upperLimit': '195.0'}, {'value': '147.9', 'groupId': 'BG003', 'lowerLimit': '110.9', 'upperLimit': '182.2'}, {'value': '142.6', 'groupId': 'BG004', 'lowerLimit': '113.9', 'upperLimit': '185.1'}, {'value': '180.4', 'groupId': 'BG005', 'lowerLimit': '140.6', 'upperLimit': '205.9'}, {'value': '157.4', 'groupId': 'BG006', 'lowerLimit': '106.9', 'upperLimit': '205.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Pounds', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2009-07-22', 'resultsFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2009-07-22', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-04', 'studyFirstPostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-∞) Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water', 'timeFrame': '0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose', 'description': 'AUC values were natural log-transformed and analyzed using an analysis of variance (ANOVA) model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.'}, {'measure': 'Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water', 'timeFrame': '0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose', 'description': 'Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.'}], 'secondaryOutcomes': [{'measure': 'AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water', 'timeFrame': '0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose', 'description': 'AUC values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.'}, {'measure': 'Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water', 'timeFrame': '0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose', 'description': 'Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heartburn']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=0208-144&kw=0208-144&tab=access', 'type': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg FCT with water.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female participant is not pregnant or lactating\n* Female of childbearing potential must use reliable means of contraception during the course of the study\n* Is in good health\n* Is able to abstain from smoking during the 24-hour periods before and during each treatment day\n\nExclusion Criteria:\n\n* Has any major systemic disorders\n* Has a history of ulcers, other Gastrointestinal (GI) disease, or GI surgery\n* Has or has a history of any illness or condition that might interfere with optimal participation in the study\n* Has a history of asthma or severe allergies to drugs or foods\n* Currently uses prescribed or non-prescribed drugs on a regular basis\n* Has a recent history of drug/alcohol abuse\n* Consumes more than 6 cups of coffee per day\n* Has unconventional or extreme dietary habits\n* Has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days\n* Has a history of allergy or intolerance to antacids\n* Is known to be pregnant or is not using reliable means of contraception'}, 'identificationModule': {'nctId': 'NCT00945750', 'briefTitle': 'A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine 20 mg Film-Coated Tablets (FCT) Compared to Famotidine 20 mg Chewable Tablets (CT) Without Water and Famotidine 20 mg Chewable Tablets (CTw) With Water (Protocol 144)', 'orgStudyIdInfo': {'id': '0208-144'}, 'secondaryIdInfos': [{'id': '2009_621', 'type': 'OTHER', 'domain': 'Merck Registration Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1: FCT with water → CT without water → CT with water', 'description': 'Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3).', 'interventionNames': ['Drug: Famotidine FCT', 'Drug: Famotidine CT']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2: CT without water → CT with water → FCT with water', 'description': 'Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).', 'interventionNames': ['Drug: Famotidine FCT', 'Drug: Famotidine CT']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3: CT with water → FCT with water → CT without water', 'description': 'Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3).', 'interventionNames': ['Drug: Famotidine FCT', 'Drug: Famotidine CT']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4: FCT with water → CT with water → CT without water', 'description': 'Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3).', 'interventionNames': ['Drug: Famotidine FCT', 'Drug: Famotidine CT']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 5: CT without water → FCT with water → CT with water', 'description': 'Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3).', 'interventionNames': ['Drug: Famotidine FCT', 'Drug: Famotidine CT']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 6: CT with water → CT without water → FCT with water', 'description': 'Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).', 'interventionNames': ['Drug: Famotidine FCT', 'Drug: Famotidine CT']}], 'interventions': [{'name': 'Famotidine FCT', 'type': 'DRUG', 'description': 'Famotidine 20 mg oral film-coated tablet taken once daily', 'armGroupLabels': ['Sequence 1: FCT with water → CT without water → CT with water', 'Sequence 2: CT without water → CT with water → FCT with water', 'Sequence 3: CT with water → FCT with water → CT without water', 'Sequence 4: FCT with water → CT with water → CT without water', 'Sequence 5: CT without water → FCT with water → CT with water', 'Sequence 6: CT with water → CT without water → FCT with water']}, {'name': 'Famotidine CT', 'type': 'DRUG', 'description': 'Famotidine 20 mg oral chewable tablet taken once daily', 'armGroupLabels': ['Sequence 1: FCT with water → CT without water → CT with water', 'Sequence 2: CT without water → CT with water → FCT with water', 'Sequence 3: CT with water → FCT with water → CT without water', 'Sequence 4: FCT with water → CT with water → CT without water', 'Sequence 5: CT without water → FCT with water → CT with water', 'Sequence 6: CT with water → CT without water → FCT with water']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}