DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets

Information source: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Lovastatin 40 mg Tablets (Drug); Lovastatin (MevacorĀ®) 40 mg 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® tablets 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/Fed State

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)

Primary outcome:

Maximum Plasma Concentration (Cmax)

Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]

Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-āˆž)]

Detailed description: 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. Fifty-four healthy, light/non/or ex-smoking, non-obese, male volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two Lovastatin dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive a standardized high-fat, high-calorie meal 30 minutes before drug administration. Thirty minutes after the start of the breakfast, a single oral dose of either the test formulation, Lovastatin (1 x 40 mg tablet), or a single oral dose of the reference formulation, MevacorĀ® (1 x 40 mg tablet) will be administered. After a 7 day washout period, on the morning of Day 8, following an overnight fast of at least 10 hours and 30 minutes after the start of a standardized high-fat, high-calorie meal, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of Lovastatin. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Vital signs will be monitored if judged necessary by the physician in charge. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.

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/mĀ²

- 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

Starting date: July 2004
Last updated: January 11, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015