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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pravastatin

• Registration Number: NCT00829309
• Lead Sponsor: Teva Pharmaceuticals USA

Brief 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.

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Results First Submitted: 2009-07-02
• Results First Submitted QC: 2009-07-02
• Results First Posted: 2009-08-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pravastatin	Pravastatin	Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
Pravachol®	Pravastatin	Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period

Primary Outcome Measures

Name	Time	Method
Cmax - Maximum Observed Concentration - Pravastatin in Plasma	Blood samples collected over 16 hour period	Bioequivalence based on Cmax
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	Blood samples collected over 16 hour period	Bioequivalence based on AUC0-t
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	Blood samples collected over 16 hour period	Bioequivalence based on AUC0-inf

Trial Locations

Locations (1)

PRACS Institute, Ltd.; 🇺🇸 Fargo, North Dakota, United States