At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 72 enrolled
Drug / intervention
Amlodipine 5mg capsule +2 moredrug
Likely dose
Amlodipine 5mg capsulefrom 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 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet Compared to Concomitant Administration of Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Amlodipine 5 mg Capsule in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study), With Influence of Food on the Bioavailability of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet
In Brief
A Phase 1 clinical trial evaluating Amlodipine 5mg capsule, T80/H12.5 mg FDC tablet, and 1 other intervention for Healthy. Completed, enrolled 72 participants across 1 site.
Detailed Summary
To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedMay 2014
Primary CompletionAug 2014
Study CompletionSep 2014
TodayJul 2026
First PostedMay 2, 2014
Enrollment StartMay 1, 2014
Primary CompletionAug 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.2 years ago
Interventions
Amlodipine 5mg capsuledrug
Amlodipine 5mg capsule
T80/H12.5 mg FDC tabletdrug
Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg FDC tablet
T80/A5/H12.5 mg FDC tabletdrug
Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg FDC tablet