NCT00830258

Pravastatin Sodium 80 mg Tablets Under Fasting Conditions

A Single-Dose, Comparative, Bioavailability Study of Two Formulations of Pravastatin Sodium 80 mg Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the comparative bioavailability between pravastatin sodium 80 mg tablets (Distributed by Teva Pharmaceuticals, USA) and Pravachol® 80 mg tablets (Bristol Myers Squibb, USA), after a single-dose in healthy subjects under fasting conditions.

Detailed description

Detailed Description Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pravastatin sodium 80 mg tablets	1 x 80 mg
DRUG	Pravachol® 80 mg tablets	1 x 80 mg

Timeline

• Start date: 2005-04-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2009-01-27
• Last updated: 2024-08-19
• Results posted: 2009-08-18

Locations

1 site across 1 country: Canada