At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 54 enrolled
Drug / intervention
Lovastatin 40 mg Tablets +1 moredrug
Likely dose
Lovastatin 40 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 Single Dose Crossover Comparative Bioavailability Study of Lovastatin 40mg Tablets in Healthy Male Volunteers/Fed State
In Brief
A Phase 1 clinical trial evaluating Lovastatin 40 mg Tablets and Lovastatin (Mevacor®) 40 mg Tablets for Healthy. Completed, enrolled 54 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2004
Primary CompletionJul 2004
First PostedMay 2008
TodayJul 2026
First PostedMay 28, 2008
Enrollment StartJul 1, 2004
Primary CompletionJul 1, 2004
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 18.1 years ago
Interventions
Lovastatin 40 mg Tabletsdrug
40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast
Lovastatin (Mevacor®) 40 mg Tabletsdrug
40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast