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

Therapeutic Equivalency Clinical Trial

Official title:
A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Non-Smoking Male and Female Subjects

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00648544
Study type Interventional
Source Viatris Inc.
Contact
Status Completed
Phase Phase 1
Start date July 2003
Completion date July 2003
View Details
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