At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
Trandolapril 4 mg Tablets +1 moredrug
Likely dose
Trandolapril 4 mg Tabletsfrom 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 Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Trandolapril 4 mg Tablets Versus Mavik® 4 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects
In Brief
A Phase 1 clinical trial evaluating Trandolapril 4 mg Tablets and Mavik® 4 mg Tablets for Healthy. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The objective of this study is to compare the rate and extent of absorption of trandolapril from a test formulation of Trandolapril 4 mg Tablets versus the reference Mavik® 4 mg Tablets under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2004
Primary CompletionNov 2004
First PostedFeb 2009
TodayJul 2026
First PostedFeb 10, 2009
Enrollment StartOct 1, 2004
Primary CompletionNov 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Trandolapril 4 mg Tabletsdrug
1 x 4 mg, single-dose fasting
Mavik® 4 mg Tabletsdrug
1 x 4 mg, single-dose fasting