At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 64 enrolled
Drug / intervention
Telmisartan/Amlodipin FDC +2 moredrug
Likely dose
Telmisartan 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Bioequivalence of Telmisartan Administrated in Two Different Ways: Both in Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg Tablet and Amlodipine 5mg Tablet in Concomitant Use in Healthy Male Volunteers. (an Open-label, Randomized, Single-dose, Four-period Replicated Crossover Study)
In Brief
A Phase 1 clinical trial evaluating Telmisartan/Amlodipin FDC, Telmisartan, and 1 other intervention for Healthy. Completed, enrolled 64 participants across 1 site.
Detailed Summary
To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in concomitant use
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedApr 2011
Primary CompletionJul 2011
TodayJul 2026
First PostedApr 29, 2011
Enrollment StartApr 1, 2011
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.2 years ago
Interventions
Telmisartan/Amlodipin FDCdrug
Telmisartan80mg/Amlodipin5mg FDC
Telmisartandrug
Telmisartan 80 mg tablet
Amlodipindrug
Amlodipin 5mg tablet