Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets - Full Text View

Sponsored by:	Mutual Pharmaceutical Company, Inc.
Information provided by:	Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:	NCT00684723

Purpose

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 after a single oral dose administered under fed conditions

Condition	Intervention	Phase
Therapeutic Equivalency	Drug: lovastatin tablets	Phase I

Drug Information available for: Lovastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Outcomes Assessor), Crossover Assignment, Bio-equivalence Study
Official Title:	A Single Dose Crossover Comparative Bioavailability Study of Lovastatin 40mg Tablets in Healthy Male Volunteers

Further study details as provided by Mutual Pharmaceutical Company, Inc.:

Primary Outcome Measures:

Bioequivalence [ Time Frame: two - three weeks ] [ Designated as safety issue: No ]

Enrollment:	54
Study Start Date:	July 2004
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental A single dose administered under fed conditions in each study period. Each period separated by a washout of 7 days	Drug: lovastatin tablets 40 mg
B: Active Comparator A single dose administered under fed conditions in each study period. Each period separated by a washout of 7 days	Drug: lovastatin tablets 40mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly signed by the volunteer
Male aged of at least 18 with a body mass index (BMI) greater than or equal to 19 and below 30 kg/m²
Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
Healthy according to the laboratory results and physical examination
Light-, non- or ex-smokers. Light smokers are defined as someone smoking 10 cigarettes or less per day, and ex-smokers are defined as someone who completely stopped smoking for at least 3 months
The informed consent must be signed by all volunteers, prior to their participation in the study

Exclusion Criteria:

Significant history of hypersensitivity to lovastatin or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs
Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
Presence of active liver disease or unexplained persistent elevations of serum transaminases
Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
Any clinically significant illness in the previous 28 days before day 1 of this study
Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.)
Participation in another clinical trial in the previous 28 days before day 1 of this study
Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
Positive urine screening of drugs of abuse
Positive results to HIV, HBsAg or anti-HCV tests

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684723

Locations

Canada, Quebec
Algorithme Pharma
Montreal, Quebec, Canada

Sponsors and Collaborators

Mutual Pharmaceutical Company, Inc.

Investigators

Principal Investigator:

Eric Sicard, MD

Algorithme Pharma Inc

More Information

Additional Information:

Recalls, Market Withdrawals and Safety Alerts This link exits the ClinicalTrials.gov site

Daily Med - Posting of Recently Submitted Labeling to the FDA This link exits the ClinicalTrials.gov site

URL Pharma Generic Division This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mutual Pharmaceutical ( Kristin Arnold, Vice President R&D )
Study ID Numbers:	LVI-P4-126
Study First Received:	May 24, 2008
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00684723 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Antimetabolites
Antilipemic Agents
Anticholesteremic Agents

Healthy
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Lovastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Lovastatin

ClinicalTrials.gov processed this record on May 07, 2009