NCT01146106

Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fasting Conditions

Single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80 mg, Bristol Myers Squibb in Healthy Volunteers.

Detailed description

Single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80mg, Bristol Myers Squibb in Healthy Volunteers. A total of 43 non-smoking subjects (31 men and 12 women) were included in this study, of which 43 finished the study according to the protocol.The study was performed as a single-dose two-way (80 mg), crossover bioequivalence study with an adequate washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned to receive the study test

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pravastatin Sodium	Pravastatin Sodium Tablets 80 mg

Timeline

• Start date: 2002-12-01
• Primary completion: 2002-12-01
• Completion: 2002-12-01
• First posted: 2010-06-17
• Last updated: 2010-06-17