Overview

Fed, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Subjects

Status:
Completed
Trial end date:
2003-07-01
Target enrollment:
Participant gender:
Summary
This study was designed to compare the rate and extent of absorption of pravastatin sodium from the following formulations under fed conditions: 1. Pravastatin Sodium 80 mg Tablets (Genpharm Inc. Canada) 2. Pravachol® 80 mg Tablets (Bristol-Myers Squibb Co., U.S.A.) Bioequivalence of these formulations was assessed for pravastatin. Based on the results from this study, these two 80 mg pravastatin tablet formulations demonstrated bioequivalence under the single-dose fed conditions.
Phase:
Phase 1
Details
Lead Sponsor:
Mylan Pharmaceuticals
Collaborator:
Genpharm ULC
Treatments:
Pravastatin