Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)

Study Overview
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Brief Summary
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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.

Detailed Description
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Fenofibrate is rapidly and completely hydrolyzed to fenofibric acid, the active moiety. The primary objective of this study is to evaluate the bioequivalence of fenofibric acid and fenofibrate under fasting conditions. Additionally, the safety and tolerability of the study treatments will be evaluated. Fifty-four healthy, non-smoking, non-obese, 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive each of two dosing regimens, fenofibric acid (Fibricor™) and fenofibrate (Tricor®) in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, fenofibric acid (1 x 105 mg tablet) or a single oral dose of the reference formulation, fenofibrate (1 x 145 mg tablet). After a 7 day washout period, on the morning of Day 8 after an overnight fast, subjects will receive the alternate regimen. Fasting will continue for 4 hours after each dose. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of fenofibric acid and fenofibrate. Subjects will be monitored throughout their participation for adverse reactions to the study drug and/or procedures. Seated blood pressure and pulse will be measured prior to each dose and approximately 2 hours post-dose. All adverse experiences, whether elicited by query, spontaneously reported, or observed by clinic staff, will be documented in the subject's case report form.

Official Title
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A Single-Dose, Bioequivalence Study of 105 mg Fenofibric Acid Tablets Versus 145 mg Tricor® (Fenofibrate) Tablets Under Fasting Conditions.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Fenofibric Acid (Fibricor™) 105 mg Tablet
* Drug: Fenofibrate (Tricor®) 145 mg Tablet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fenofibric Acid (Fibricor™)<br>1 x 105 mg fenofibric acid (Fibricor™)tablet administered after an overnight fast of at least 10 hours | Drug: Fenofibric Acid (Fibricor™) 105 mg Tablet<br>* 1 x 105 mg fenofibric acid (Fibricor™) tablet administered after an overnight fast of at least 10 hours<br>* Other names: (Fibricor™);|
| Experimental: Fenofibrate (Tricor®)<br>1 x 145 mg fenofibrate (Tricor®) tablet administered after an overnight fast of at least 10 hours | Drug: Fenofibrate (Tricor®) 145 mg Tablet<br>* 1 x 145 mg Fenofibrate (Tricor®) tablet administered after an overnight fast of at least 10 hours<br>* Other names: (Tricor®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 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 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration. | 
| The Area Under the Plasma Concentration Versus Time Curve From Time 0 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 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy, pharmacokinetics, therapeutic equivalency, fasting, procetofen, fenofibric acid