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Pravastatin Sodium 40 mg Tablets Food Challenge Study

NCT00834847 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-01-09

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

pravastatin

40 mg tablet

DRUG

Pravachol®

40 mg Tablet

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Dan Yeung, MD · Pharma Medica

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-08-31
Primary Completion
2000-09-30
Completion
2000-09-30

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 NCT00834847 on ClinicalTrials.gov