Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets
Condition: Healthy
Intervention: Lovastatin 40 mg Tablets; Lovastatin (Mevacor®) 40 mg Tablets
Intervention description: 40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast; 40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 54.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Therapeutic Equivalency

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.
    

Eligibility 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