Phase 1
Completed N=54
Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets
Healthy
Source: ClinicalTrials.gov NCT00684723 ↗
Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) — 9.26; 10.01 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) |
9.26; 10.01 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] |
47.86; 51.64 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] |
48.72; 52.98 | — |
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
Data sourced from ClinicalTrials.gov (NCT00684723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.