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Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets

NCT00684723 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2010-01-20

Study results available
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Summary

The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Lovastatin 40 mg Tablets

40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast

DRUG

Lovastatin (Mevacor®) 40 mg Tablets

40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, MD · Algorithme Pharma Inc

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2004-07-31
Completion
2004-07-31

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 NCT00684723 on ClinicalTrials.gov