NCT00834847

Pravastatin Sodium 40 mg Tablets Food Challenge Study

A Relative Bioavailability Food Challenge Study of Pravastatin Sodium 40 mg Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the relative bioavailability of pravastatin 40 mg tablets with that of Pravachol 40 mg tablets in healthy adult male subjects under non-fasting conditions. A second objective is to compare the difference in plasma levels after dosing the test formulation with and without food.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	pravastatin	40 mg tablet
DRUG	Pravachol®	40 mg Tablet

Timeline

• Start date: 2000-08-01
• Primary completion: 2000-09-01
• Completion: 2000-09-01
• First posted: 2009-02-03
• Last updated: 2020-01-09

Locations

1 site across 1 country: Canada