NCT00829309

Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions

A Relative Bioavailability Study of 80 mg Pravastatin Sodium Tablets Under Non-Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study compared the relative bioavailability (rate and extent of absorption) of Pravastatin Sodium Tablets 80 mg by Teva Pharmaceutical Industries, Ltd. with that of Pravachol® Tablets 80 mg by Bristol-Myers Squibb Company following a single oral dose (1 x 80 mg tablet)in healthy adult male subjects administered under non-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	80 mg Tablet
DRUG	Pravastatin	80 mg Tablets

Timeline

• Start date: 2005-03-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2009-01-27
• Last updated: 2024-08-20
• Results posted: 2009-08-18

Locations

1 site across 1 country: United States