NCT00650221

Fasting Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Subjects

A Two-Way Crossover, Open-Label, Single-Dose, Fasting, 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: 43 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the rate and extent of absorption of pravastatin sodium from a test formulation of Pravastatin Sodium 80 mg Tablets versus the reference Pravachol® 80 mg Tablets under fasting conditions. Based on the results from this study, the two 80 mg pravastatin tablet formulations demonstrated bioequivalence under the single-dose fasting conditions.

Conditions

• Therapeutic Equivalency

Interventions

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

Timeline

• Start date: 2003-06-01
• 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