Phase 1 Completed N=54 Randomized Basic Science

Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid

Healthy

Source: ClinicalTrials.gov NCT00961259 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2009

Primary outcomePrimary: Maximum Plasma Concentration (Cmax) — 3,569.47; 10,708.40; 11,014.93; 11,202.87 ng/mL

Summary

This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each dose is administered under fasted conditions. Safety and tolerability of these regimens will also be evaluated.

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Plasma Concentration (Cmax)	3,569.47; 10,708.40; 11,014.93; 11,202.87	—
PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]	49,419.89; 148,259.66; 131,976.95; 135,119.10	—
PRIMARY The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)	58,304.35; 174,913.04; 142,858.88; 147,555.58	—

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 fenofibric acid

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Data sourced from ClinicalTrials.gov (NCT00961259). 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.