At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Amlodipine Besylate +1 moredrug
Likely dose
Amlodipine Besylate 10 mgfrom 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, Fed, Bioequivalence Study of Amlodipine 10 mg Tablets Versus Norvasc® 10 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects
In Brief
A Phase 1 clinical trial evaluating Amlodipine Besylate and Norvasc® for Healthy. Completed, enrolled 28 participants across 1 site.
Detailed Summary
The objective of this study is to compare the rate and extent of absorption of amlodipine from a test formulation of Amlodipine Besylate Tablets, 10 mg versus the reference Norvasc® 10 mg Tablets under fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2003
Primary CompletionMay 2003
First PostedFeb 2009
TodayJul 2026
First PostedFeb 11, 2009
Enrollment StartApr 1, 2003
Primary CompletionMay 1, 2003
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Amlodipine Besylatedrug
10 mg Tablet
Norvasc®drug
10 mg Tablet