Four Arm Food Effect Study of Fenofibric Acid Tablets

Study Overview
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Brief Summary
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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.

Detailed Description
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The primary objective of this study is to determine 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. Forty healthy, non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 45 years old will receive a single oral dose of fenofibric acid in one of four randomly assigned sequences of meal conditions each separated by a 7 day washout period. On study Days 1, 8, 15 and 22 each subject will receive a single oral dose (1 x 105 mg tablet) of fenofibric acid following an overnight fast of at least 10 hours or with a low-fat meal, standard meal, or high-fat/high-calorie meal according to their randomization sequence. Subjects will fast for at least 4.25 hours after dosing in each of the four dosing conditions. 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. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Seated blood pressure and heart rate will be measured prior to dosing and at 2 hours post-dose. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.

Official Title
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A Four Arm, Single-Dose, Food Effect Evaluation With 105 mg Fenofibric Acid Tablets Administered in a Fasted State and Three Different Fed Conditions, Low-Fat/Low Calorie Meal, Standard Meal, and High-Fat/High Calorie Meal

Conditions
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Healthy

Intervention / Treatment
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* Drug: Fenofibric Acid 105 mg Tablet
* Drug: Fenofibric Acid 105 mg Tablet
* Drug: Fenofibric Acid 105 mg Tablet
* Drug: Fenofibric Acid 105 mg Tablet


Participation Criteria
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Eligibility Criteria
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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

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 105 mg - Low-Fat Meal<br>Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast. | Drug: Fenofibric Acid 105 mg Tablet<br>* One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.<br>|
| Experimental: Fenofibric Acid 105 mg - Standard Meal<br>Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a standard breakfast. | Drug: Fenofibric Acid 105 mg Tablet<br>* One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast<br>|
| Experimental: Fenofibric Acid 105 mg - High-Fat/High-Calorie Meal<br>Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast. | Drug: Fenofibric Acid 105 mg Tablet<br>* One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.<br>|
| Experimental: Fenofibric Acid 105 mg - Fasted State<br>Fenofibric Acid 105 mg tablet administered after an overnight fast of at least 10 hours | Drug: Fenofibric Acid 105 mg Tablet<br>* One 105 mg tablet administered after an overnight fast of at least 10 hours.<br>|

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 blood samples drawn immediately prior to dosing and then 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 dose 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 blood samples drawn immediately prior to dosing and then 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 dose 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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pharmacokinetics