At a glance
ClinicalIndex Comparison RecordStandardized 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/Amlodipine 5 mg Fixed-dose Combination Tablet and Hydrochlorothiazide 12.5 mg Tablet in Healthy Male Subjects : an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study
In Brief
A Phase 1 clinical trial evaluating T80/A5 mg FDC tablet, H12.5 mg tablet, and 3 other interventions for Healthy. Completed, enrolled 72 participants across 1 site.
Detailed Summary
The study will be performed as an open-label, randomised, single-dose, two-sequence, four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be randomised to 2 groups. The subjects are administrated either T80/A5/H12.5 mg FDC tablet once or T80/A5 mg FDC tablet and hydrochlorothiazide (HCTZ) 12.5 mg tablet once in each period. The length of admission will be 7 days in each period.
Study Details
Timeline
Interventions
A Telmisartan 80 mg/ Amlodipine 5 mg FDC tablet
A Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet
A HCTZ 12.5 mg tablet