Overview

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

Status:
Completed
Trial end date:
2003-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Mylan Pharmaceuticals
Collaborator:
Genpharm ULC
Treatments:
Pravastatin