At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Telmisartan/Amlodipine Combination Tablet +1 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.
A Single-Dose, Comparative Bioavailability Study of Telmisartan/Amlodipine 80 mg/10 mg Tablets Versus Micardis 80 mg Tablets With Norvasc 10 mg Tablets Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Telmisartan/Amlodipine Combination Tablet and Amlodipine Monocomponent for Hypertension. Completed, enrolled 28 participants across 1 site.
Detailed Summary
This study will be an open-label, randomized, two-treatment, two-period, two-sequence crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer Ingelheim Pharma GmbH \& Co. KGs 80 mg telmisartan/10 mg amlodipine fixed dose combination tablet to the corresponding mono-component amlodipine tablets, 10 mg (Pfizers Norvasc).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedJan 2011
Primary CompletionFeb 2011
TodayJul 2026
First PostedJan 19, 2011
Enrollment StartJan 1, 2011
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.5 years ago
Interventions
Telmisartan/Amlodipine Combination Tabletdrug
Combination Tablet
Amlodipine Monocomponentdrug
Active Comparator