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

NCT00829309 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-08-20

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Pravastatin

80 mg Tablet

DRUG

Pravastatin

80 mg Tablets

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • James D Carlson, Pharm D · PRACS Institute, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2005-03-31
Completion
2005-03-31

Countries

  • United States

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 NCT00829309 on ClinicalTrials.gov