Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pravachol®; Drug: pravastatin sodium

• Registration Number: NCT00834379
• Lead Sponsor: Teva Pharmaceuticals USA

Brief Summary

The objective of this study is to compare the relative bioavailability of pravastatin sodium 40 mg tablets with that of Pravachol® 40 mg tablets in healthy adult male subjects under fasting conditions.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2000-09
• Study Completion: 2000-09
• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-03
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pravachol®	Pravachol®	Pravachol® 40 mg Tablet (reference) dosed in first period followed by Pravastatin 40 mg Tablet (test) dosed in second period
Pravastatin	pravastatin sodium	Pravastatin 40 mg Tablet (test) dosed in first period followed by Pravachol® 40 mg Tablet (reference) dosed in second period

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on Cmax and AUC	3 weeks

Trial Locations

Locations (1)

Pharma Medica Research Inc.; 🇨🇦 Toronto, Ontario, Canada