At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
Amlodipine-benazepril 10 mg-20 mg capsules +1 moredrug
Likely dose
Amlodipine-benazepril 10 mg-20 mg capsulesfrom 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.
Randomized, 2-way, Crossover, Bioequivalence Study of Amlodipine-Benazepril 10mg-20mg Capsules and Lotrel® Administered as 1 x 10 Mg-20 mg Capsule in Healthy Subjects Under Fasting Conditions.
In Brief
A Phase 1 clinical trial evaluating Amlodipine-benazepril 10 mg-20 mg capsules and Lotrel® 10 mg-20 mg capsule for Healthy. Completed, enrolled 48 participants across 2 sites.
Detailed Summary
The objective of this study is to compare the rate and extent of absorption of amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered as 1 x 10 mg capsule under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2004
Primary CompletionMay 2004
First PostedFeb 2009
TodayJul 2026
First PostedFeb 3, 2009
Enrollment StartApr 1, 2004
Primary CompletionMay 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Amlodipine-benazepril 10 mg-20 mg capsulesdrug
1 x 10-20 mg
Lotrel® 10 mg-20 mg capsuledrug
1 x 10-20 mg