Phase 1 Completed N=37 Randomized Basic Science

Four Arm Food Effect Study of Fenofibric Acid Tablets

Healthy

Source: ClinicalTrials.gov NCT00960856 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2009

Primary outcomePrimary: Maximum Plasma Concentration (Cmax) — 9,806.74; 9,854.39; 7,950.75; 12,061.67 ng/mL

Summary

The primary objective of this study is to characterize the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption. Additionally, the safety and tolerability of this dose and regimen of fenofibric acid will be evaluated.

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Plasma Concentration (Cmax)	9,806.74; 9,854.39; 7,950.75; 12,061.67	—
PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]	132,636.84; 134,928.11; 134,814.42; 139,975.28	—
PRIMARY The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)	145,827.10; 148,367.21; 148,488.53; 152,571.61	—

Eligibility Criteria

Inclusion Criteria

Healthy adults between the ages of 18 and 45
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 (NCT00960856). 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.