NCT00648544

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Therapeutic Equivalency

Interventions

Type	Name	Description
DRUG	Pravastatin	Single-dose 80 mg oral immediate-release tablet
DRUG	Pravastatin	Single-dose 80 mg oral immediate-release tablets

Timeline

• Start date: 2003-07-01
• Primary completion: 2003-07-01
• Completion: 2003-07-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: Canada