At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
Pravastatin sodium 80 mg tablets +1 moredrug
Likely dose
Pravastatin sodium 80 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, Comparative, Bioavailability Study of Two Formulations of Pravastatin Sodium 80 mg Tablets Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Pravastatin sodium 80 mg tablets and Pravachol® 80 mg tablets for Healthy. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate the comparative bioavailability between pravastatin sodium 80 mg tablets (Distributed by Teva Pharmaceuticals, USA) and Pravachol® 80 mg tablets (Bristol Myers Squibb, USA), after a single-dose in healthy subjects under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2005
Primary CompletionApr 2005
First PostedJan 2009
TodayJul 2026
First PostedJan 27, 2009
Enrollment StartApr 1, 2005
Primary CompletionApr 1, 2005
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Pravastatin sodium 80 mg tabletsdrug
1 x 80 mg
Pravachol® 80 mg tabletsdrug
1 x 80 mg