CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
amlodipine/telmisartan/combinationdrug
Likely dose
amlodipine/telmisartan/combination 5mgfrom record
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Search/NCT01181011
NCT01181011Phase 1Completed
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A Single-centre, Randomized, Open-label, Three-period Crossover Pharmacokinetic Study of 80 mg Telmisartan / 5 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Chinese Subjects

Boehringer Ingelheim·interventional·Posted Aug 13, 2010·Updated Jul 24, 2014

In Brief

A Phase 1 clinical trial evaluating amlodipine/telmisartan/combination for Healthy. Completed, enrolled 28 participants across 1 site.

Detailed Summary

To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose combination after single dose in healthy Chinese subjects. To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine, following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5) tablet alone and in combination, in healthy Chinese subjects. To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy Chinese subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 13, 2010
Enrollment StartAug 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.9 years ago

Interventions

amlodipine/telmisartan/combinationdrug

patient would take amlodipine(5mg)/telmisartan(80mg)/combination(T80+A5mg) single dose in random order, and each dosage will be separated in 21 days interval.