MedTrace Logo

Fasting Bioavailability Study of Lovastatin Tablets and Mevacor Tablets

NCT00685685 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2010-01-20

Study results available
· View outcomes & findings →

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 fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Lovastatin 40 mg tablets

40 mg tablet administered after an overnight fast of at least 10 hours

DRUG

Lovastatin (Mevacor®) 40 mg Tablets

40 mg tablet administered after an overnight fast of at least 10 hours

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2004-10-31
Completion
2004-10-31

Countries

  • Canada

Study Locations

More Related Trials

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 NCT00685685 on ClinicalTrials.gov