Phase 1
Completed N=54
Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)
Healthy
Source: ClinicalTrials.gov NCT00961116 ↗
Enrolled (actual)
54
Serious AEs
—
Results posted
Oct 2009
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) — 12,344.00; 10,940.05 ng/mL
Summary
This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers under fasting conditions. A secondary objective is to characterize the pharmacokinetic profile of fenofibric acid when administered as a single 105 mg dose to healthy volunteers in a fasted state. Safety and tolerability of this regimen will also be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) |
12,344.00; 10,940.05 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] |
159,866.23; 170,727.10 | — |
| PRIMARY The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞) |
176,816.78; 188,331.49 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy adults 18-45 years of age
- Non-smoking
- Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures)
- Body mass index (BMI) less than 30
- Medically healthy on the basis of medical history and physical examination
- Hemoglobin > or = to 12g/dL
- Completion of the screening process within 28 days prior to dosing
- Provision of voluntary written informed consent
Exclusion Criteria
- Recent participation (within 28 days) in other research studies
- Recent significant blood donation or plasma donation
- Pregnant or lactating
- Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
- Recent (2-year) history or evidence of alcoholism or drug abuse
- History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
- Drug allergies to fenofibrate (fenofibric acid)
Data sourced from ClinicalTrials.gov (NCT00961116). 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.