Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-03 @ 9:36 AM
Study NCT ID:
NCT01494402
Status:
COMPLETED
Last Update Posted:
2012-04-09
First Post:
2011-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-06', 'studyFirstSubmitDate': '2011-12-15', 'studyFirstSubmitQcDate': '2011-12-16', 'lastUpdatePostDateStruct': {'date': '2012-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in terms of Area under the plasma concentration(AUCτ).', 'timeFrame': 'Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6', 'description': 'All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.'}, {'measure': 'Description of bioequivalence of D961S to combination of esomeprazole + buffered ASA in term maximum plasma concentration (Cmax,ss)', 'timeFrame': 'Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6', 'description': 'All PK variables at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.'}], 'secondaryOutcomes': [{'measure': 'Description of D961S PK profile comparing to esomeprazole and ASA combination in terms of AUC0-t,ss, mean residence time (MRT), time to reach Cmax (tmax,ss) and t1/2,ss of esomeprazole and ASA, and AUCτ, Cmax,ss, AUC0-t,ss, MRT, tmax,ss and t1/2,ss of SA', 'timeFrame': 'Baseline, which is 30 minutes before dose at day 5 of treatment period, till day 6', 'description': 'All PK variables and plasma concentrations of esomeprazole, ASA and SA at each time point will be listed by subject and summarised for each treatment using appropriate descriptive statistics.'}, {'measure': 'Description of Safety and tolerability profile of esomeprazole in combination with ASA in terms of adverse events, clinical laboratory tests, blood pressure, pulse rate and body temperature.', 'timeFrame': 'Pre-entry, Day 5 of treatment period and follow up (5-7 days after last dose)', 'description': 'Descriptive statistics will be provided for all safety variables, and the analyses will be performed according to the actual treatment. No formal comparison will be performed.'}]}, 'conditionsModule': {'keywords': ['Healthy volunteer, Japanese males, homo-EM'], 'conditions': ['Bioequivalence Study']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA following repeated administration in healthy male Japanese subjects.', 'detailedDescription': 'A Phase I, Open label, Randomized, Single center, 2 way Crossover Bioequivalence Study Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) with a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Japanese males 20-45 years of age\n* Classified as homo-EM\n* Negative for HIV, Hepatitis B, Hepatitis C and syphilis\n* Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)\n* Body weight 50-85 kg\n\nExclusion Criteria:\n\n* Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization\n* Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease\n* Need for concomitant medication in the study\n* Past or present NSAIDs induced asthma\n* History of bleeding diathesis'}, 'identificationModule': {'nctId': 'NCT01494402', 'briefTitle': 'Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Open Label, Randomized, Single Center, 2 Way Crossover Bioequivalence Study Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) With a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'D961SC00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D961S', 'description': '2 way crossover', 'interventionNames': ['Drug: D961S']}, {'type': 'EXPERIMENTAL', 'label': 'esomeprazole + buffered acetylsalicylic acid', 'description': '2 way crossover', 'interventionNames': ['Drug: Esomeprazole', 'Drug: Buffered acetylsalicylic acid']}], 'interventions': [{'name': 'D961S', 'type': 'DRUG', 'description': 'Oral gelatine capsule', 'armGroupLabels': ['D961S']}, {'name': 'Esomeprazole', 'type': 'DRUG', 'otherNames': ['Nexium® capsule 20 mg'], 'description': 'Oral HPMC capsule', 'armGroupLabels': ['esomeprazole + buffered acetylsalicylic acid']}, {'name': 'Buffered acetylsalicylic acid', 'type': 'DRUG', 'otherNames': ['Bufferin Combination Tablet A81'], 'description': 'Tablet', 'armGroupLabels': ['esomeprazole + buffered acetylsalicylic acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hakata', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Study site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}