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Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets

Information source: Mutual Pharmaceutical Company, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Therapeutic Equivalency

Intervention: lovastatin tablets (Drug); lovastatin tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mutual Pharmaceutical Company, Inc.

Official(s) and/or principal investigator(s):
Eric Sicard, MD, Principal Investigator, Affiliation: Algorithme Pharma Inc

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 after a single oral dose administered under fed conditions

Clinical Details

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

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

Primary outcome: Bioequivalence

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

Algorithme Pharma, Montreal, Quebec, Canada
Additional Information

Recalls, Market Withdrawals and Safety Alerts

Daily Med - Posting of Recently Submitted Labeling to the FDA

URL Pharma Generic Division

Starting date: July 2004
Ending date: July 2004
Last updated: May 27, 2008

Page last updated: June 20, 2008

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