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

Therapeutic Equivalency Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00650221
Study type Interventional
Source Viatris Inc.
Contact
Status Completed
Phase Phase 1
Start date June 2003
Completion date July 2003
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