Pravastatin Sodium 40 mg Tablets Food Challenge Study

Phase 1

Completed

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

• Registration Number: NCT00834847
• Lead Sponsor: Teva Pharmaceuticals USA

Brief 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

Study Timeline

• Study Start: 2000-08
• 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: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pravachol®	Pravachol®	Reference product under fed conditions dosed in first period followed by test product dosed under either fed or fasted conditions in second and third periods
Pravastatin	pravastatin	Test product under fed conditions dosed in first period followed by either test product dosed under fasting conditions or reference product dosed under fed conditions in second and third periods
Pravastatin fast	pravastatin	Test product under fasting conditions dosed in first period followed by either test or reference product dosed under fed conditions in second and third periods

Primary Outcome Measures

Name	Time	Method
Cmax - Maximum Observed Concentration	Blood samples collected over 24 hour period
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)	Blood samples collected over 24 hour period
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)	Blood samples collected over 24 hour period

Secondary Outcome Measures

Name	Time	Method
Cmax - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions	Blood samples collected over 24 hour period
AUC0-inf - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions	Blood samples collected over 24 hour period
AUC0-t - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions	Blood samples collected over 24 hour period

Trial Locations

Locations (1)

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