At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Telmisartan/Amlodipine +2 moredrug
Likely dose
Not stated in 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.
Pharmacokinetics of Multiple Oral Doses of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet, Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet at Steady State in Healthy Male Subjects: an Open-label, Randomised, Multiple-dose, Three Treatment, Three-period, Six-sequence Crossover Study
In Brief
A Phase 1 clinical trial evaluating Telmisartan/Amlodipine, Telmisartan/Amlodipine/HCTZ, and 1 other intervention for Healthy. Completed, enrolled 36 participants across 1 site.
Detailed Summary
To assess drug drug interaction through pharmacokinetics investigation at steady state of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations in healthy Japanese male subjects
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJul 2014
First PostedJul 2014
Primary CompletionOct 2014
TodayJul 2026
First PostedJul 8, 2014
Enrollment StartJul 1, 2014
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.0 years ago
Interventions
Telmisartan/Amlodipinedrug
Telmisartan/Amlodipine fixed-dose combination
Telmisartan/Amlodipine/HCTZdrug
Telmisartan/Amlodipine/HCTZ fixed-dose combination
Telmisartan/HCTZdrug
Telmisartan/HCTZ fixed-dose combination