Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-28 @ 8:50 PM
Study NCT ID:
NCT02262858
Status:
COMPLETED
Last Update Posted:
2014-10-13
First Post:
2014-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of Telmisartan/ HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Male Volunteers II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077333', 'term': 'Telmisartan'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], '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'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D049971', 'term': 'Thiazides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-10', 'studyFirstSubmitDate': '2014-10-10', 'studyFirstSubmitQcDate': '2014-10-10', 'lastUpdatePostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'Cmax (maximum measured concentration of the analyte in plasma)', 'timeFrame': 'up to 72 hours after drug administration'}], 'secondaryOutcomes': [{'measure': 'AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'tmax (time from dosing to the maximum concentration of the analyte in plasma)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'λz (terminal rate constant of the analyte in plasma)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 't1/2 (terminal half-life of the analyte in plasma)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'MRTpo (mean residence time of the analyte in the body after po administration)', 'timeFrame': 'up to 72 hours after drug administration'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': 'up to 7 days after last drug administration'}, {'measure': 'Number of subjects with clinically significant changes in vital signs', 'timeFrame': 'up to 7 days after last drug administration', 'description': 'blood pressure, pulse rate'}, {'measure': 'Number of subjects with clinically significant changes in 12 lead ECG', 'timeFrame': 'up to 7 days after last drug administration'}, {'measure': 'Number of subjects with clinically significant changes in laboratory tests', 'timeFrame': 'up to 7 days after last drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Study to investigate the bioequivalence of 80 mg telmisartan/12.5 mg hydrochlorothiazide (HCTZ) fixed dose combination compared with its monocomponents'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy males according to the following criteria:\n\n Based upon a complete medical history, physical finding, physical examination (measurements of height and body weight), vital signs (blood pressure, pulse rate), 12- lead ECG, clinical laboratory tests (including gastric acid (GA) test)\n * No finding of clinical relevance\n * No evidence of a clinically relevant concomitant disease\n2. Age ≥ 20 years and Age ≤ 35 years\n3. Body weight ≥ 50 kg\n4. Body mass index (BMI) ≥ 17.6 kg/m2 and BMI ≤ 25.0 kg/m2\n5. Signed and dated written informed consent prior to admission to the study\n\nExclusion Criteria:\n\n1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n2. Surgery of gastrointestinal tract (except appendectomy)\n3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n4. History of relevant orthostatic hypotension, fainting spells or blackouts\n5. Chronic or relevant acute infections\n6. History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator\n7. Positive result for hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV), syphilitic test or human immunodeficiency virus (HIV) antigen-antibody test\n8. Intake of drugs with a long half-life (≥ 24 hours) within at least 1 month prior to administration or within a period of 10 or less half-lives of the respective drugs during the trial\n9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial\n10. Participation in another trial with an investigational drug within 4 months prior to administration or during the trial\n11. Smoker (20 or more cigarettes/day)\n12. Inability to refrain from smoking during hospitalization\n13. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)\n14. Drug abuse\n15. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)\n16. Excessive physical activities (within one week prior to administration or during the trial)\n17. Any laboratory value outside the reference range that was of clinical relevance\n18. Inability to comply with dietary regimen of study centre\n19. Any other volunteers whom the investigator or sub investigator did not allow to participate in this study'}, 'identificationModule': {'nctId': 'NCT02262858', 'briefTitle': 'Bioequivalence of Telmisartan/ HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Male Volunteers II', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Bioequivalence of 80 mg Telmisartan/12.5 mg HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Male Volunteers II (an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study)', 'orgStudyIdInfo': {'id': '502.495'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telmisartan and HCTZ (fix dose combination)', 'interventionNames': ['Drug: Telmisartan and HCTZ']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telmisartan and HCTZ (monocomponent)', 'interventionNames': ['Drug: Telmisartan', 'Drug: HCTZ']}], 'interventions': [{'name': 'Telmisartan and HCTZ', 'type': 'DRUG', 'armGroupLabels': ['Telmisartan and HCTZ (fix dose combination)']}, {'name': 'Telmisartan', 'type': 'DRUG', 'armGroupLabels': ['Telmisartan and HCTZ (monocomponent)']}, {'name': 'HCTZ', 'type': 'DRUG', 'armGroupLabels': ['Telmisartan and HCTZ (monocomponent)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}