Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets

NCT00684723 | Completed Phase 1 Results

• 1 other identifier: LVI-P4-126
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Therapeutic Equivalency

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  The maximum or peak concentration that the drug reaches in the plasma.

  serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.

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

  The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.

  serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.

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

  The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.

  serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.

Study Arms (2)

Lovastatin 40 mg Tablet

EXPERIMENTAL

A single dose of Lovastatin 40 mg administered under fed conditions.

Drug: Lovastatin 40 mg Tablets

Lovastatin (Mevacor®) 40 mg Tablet

EXPERIMENTAL

A single dose of Lovastatin (Mevacor®) 40 mg administered under fed conditions.

Drug: Lovastatin (Mevacor®) 40 mg Tablets

Interventions

Lovastatin 40 mg Tablets DRUG

40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast

Lovastatin 40 mg Tablet

Lovastatin (Mevacor®) 40 mg Tablets DRUG

40 mg tablet administered 30 minutes following the start of a standardized high-fat, high-calorie breakfast

Also known as: Mevacor®

Lovastatin (Mevacor®) 40 mg Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

Study Sites (1)

Algorithme Pharma

Montreal, Quebec, Canada

Location

Related Links

• Recalls, Market Withdrawals and Safety Alerts
• Daily Med - Posting of Recently Submitted Labeling to the FDA

MeSH Terms

Interventions

Lovastatin

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Mutual Pharmaceutical Company, Inc.

clinicaltrials@urlmutual.com

215-697-1743

Study Officials

• Eric Sicard, MD

  Algorithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 24, 2008
• First Posted: May 28, 2008
• Study Start: July 1, 2004
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2004
• Last Updated: January 20, 2010
• Results First Posted: December 30, 2009

Record last verified: 2010-01

Locations

CA (1)