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Fed, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Subjects

NCT00648544 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-04-24

No results posted yet for this study

Summary

This study was designed to compare the rate and extent of absorption of pravastatin sodium from the following formulations under fed conditions:

1. Pravastatin Sodium 80 mg Tablets (Genpharm Inc. Canada)
2. Pravachol® 80 mg Tablets (Bristol-Myers Squibb Co., U.S.A.) Bioequivalence of these formulations was assessed for pravastatin.

Based on the results from this study, these two 80 mg pravastatin tablet formulations demonstrated bioequivalence under the single-dose fed conditions.

Conditions

  • Therapeutic Equivalency

Interventions

DRUG

Pravastatin

Single-dose 80 mg oral immediate-release tablet

DRUG

Pravastatin

Single-dose 80 mg oral immediate-release tablets

Sponsors & Collaborators

  • Genpharm ULC

    collaborator INDUSTRY

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Paul Tam, MD · Biovail Contract Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2003-07-31
Completion
2003-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00648544 on ClinicalTrials.gov