At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
Ramipril 10 mg capsule +1 moredrug
Likely dose
Ramipril 10 mg capsulefrom 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 Ramipril 10 mg Capsule and Altace® Administered as the Content of 1 x 10 mg Capsule Mixed With Applesauce in Healthy Subjects Under Fasting Conditions.
In Brief
A Phase 1 clinical trial evaluating Ramipril 10 mg capsule and Altace® 10 mg capsule for Healthy. Completed, enrolled 40 participants across 2 sites.
Detailed Summary
The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg capsule (test) versus Altace® (reference) administered as the content of 1 x 10 mg capsule mixed with applesauce under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2004
Primary CompletionOct 2004
First PostedJan 2009
TodayJul 2026
First PostedJan 27, 2009
Enrollment StartAug 1, 2004
Primary CompletionOct 1, 2004
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.4 years ago
Interventions
Ramipril 10 mg capsuledrug
1 x 10 mg
Altace® 10 mg capsuledrug
1 x 10 mg