Official Title: “A Single Dose Crossover Comparative Bioavailability Study of Lovastatin Tablets 40mg in Healthy Male Volunteers”

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 fasting conditions

Study Type: Interventional

Study Design: Other, Randomized, Single Blind (Outcomes Assessor), Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: October 2004

Intervention(s) in this Clinical Trial

• Drug: lovastatin tablets
  • 40 mg
• Drug: lovastatin tablets
  • 40 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • A single dose administered under fasting conditions in each study period. Each period separated by a washout of 7 days
• Active Comparator: B
  • A single dose administered under fasting conditions in each study period. Each period separated by a washout of 7 days

Primary Measures

• Bioequivalence
  • Time Frame: two - three weeks
    Safety Issue?: No

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 form 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
• 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 (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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mutual Pharmaceutical Company, Inc.

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00685685

Study ID Number: LVI-P4-125

ClinicalTrials.gov Identifier: NCT00685685

Health Authority: United States: Institutional Review Board

Recalls, Market Withdrawals and Safety Alerts

Daily Med - Posting of Recently Submitted Labeling to the FDA

URL Pharma Generic Division