Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-03-04 @ 10:24 PM
Study NCT ID:
NCT02262559
Status:
COMPLETED
Last Update Posted:
2014-10-13
First Post:
2014-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of BIBR 277 Tablet Compared With Capsule in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077333', 'term': 'Telmisartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-09', 'studyFirstSubmitDate': '2014-10-09', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (maximum observed concentration of the Telmisartan in plasma)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'AUC0-72hr (area under the concentration-time curve of the Telmisartan in plasma from zero time to 72hr', 'timeFrame': 'up to 72 hours after drug administration'}], 'secondaryOutcomes': [{'measure': 'Individual time courses of the Telmisartan plasma concentrations', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'tmax (time to reach Cmax)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 't1/2 (terminal half-life of the Telmisartan in plasma)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'AUC0-∞(area under the concentration-time curve of Telmisartan in plasma from zero time to infinity)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'MRT0-∞ (total mean residence time of Telmisartan molecules in the body)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': 'up to 72 hours after last drug administration'}, {'measure': 'Number of subjects with clinically significant findings in vital signs', 'timeFrame': 'up to 72 hours after last drug administration', 'description': 'blood pressure, pulse rate'}, {'measure': 'Number of subjects with clinically significant findings in laboratory tests', 'timeFrame': 'up to 72 hours after last drug administration'}, {'measure': 'Number of subjects with clinically significant findings in ECG', 'timeFrame': 'up to 72 hours after last drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277 capsule'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>= 20 and \\<= 35 years\n2. Weight: BMI \\>= 17.6 and \\<= 26.4 (Weight (kg) / Height (m)2)\n3. Subjects judged by the investigator to be eligible as study subjects, with no clinically significant findings after screening\n4. Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent\n\nExclusion Criteria:\n\n1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n3. Chronic or relevant acute infections\n4. History of hepatic disorder (e.g., biliary cirrhosis, cholestasis)\n5. History of serious renal disorder\n6. History of or present bilateral renal artery stenosis or lack of unilateral kidney accompanying arterial stenosis\n7. History of or present cerebrovascular disorder\n8. History of hyperkalemia\n9. History of hypersensitivity to active ingredient (Telmisartan) or other angiotensin II receptor antagonists\n10. History of or present orthostatic hypotension or faint\n11. Surgery of gastrointestinal tract (except appendectomy)\n12. History of alcohol or drug abuse\n13. Participation to another trial with an investigational drug within 4 months prior to the trial\n14. Whole blood donation more than 400 mL within 3 months prior to the trial\n15. Whole blood donation more than 100 mL within 1 month prior to the trial\n16. Donation of constituent of blood of more than 400 mL within 1 month prior to the trial\n17. Any medication which might influence the result of the trial within 10 days prior to the trial\n18. Excessive physical activities within 7 days prior to the trial\n19. Alcohol drinking within 3 days prior to the trial\n20. Inability to comply with restriction of protocol\n21. Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study'}, 'identificationModule': {'nctId': 'NCT02262559', 'briefTitle': 'Bioequivalence of BIBR 277 Tablet Compared With Capsule in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Bioequivalence Study of BIBR 277 Tablet (Erythritol Based) Compared With Its Capsule Formation in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': '502.414'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIBR 277 tablet', 'interventionNames': ['Drug: BIBR 277 tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BIBR 277 capsule', 'interventionNames': ['Drug: BIBR 277 capsule']}], 'interventions': [{'name': 'BIBR 277 tablet', 'type': 'DRUG', 'otherNames': ['Telmisartan'], 'armGroupLabels': ['BIBR 277 tablet']}, {'name': 'BIBR 277 capsule', 'type': 'DRUG', 'otherNames': ['Telmisartan'], 'armGroupLabels': ['BIBR 277 capsule']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}