Conditions: Healthy
Keywords: healthy pharmacokinetics therapeutic equivalency
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 54
Healthy volunteers: yes

Brief summary:
This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition. Safety and tolerability of this regimen will also be evaluated.

Detailed description:
Fenofibrate is rapidly and completely hydrolyzed to fenofibric acid, the active moiety. The primary objective of this study is to evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition. Additionally, the safety and tolerability of this dosing regimen 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 and fenofibrate) in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, 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) 30 minutes after the initiation of a standard breakfast. After a 7 day washout period, on the morning of Day 8, subjects will receive the alternate regimen 30 minutes after the initiation of a standard breakfast. 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. 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.

Arms:
arm 1: 1 x 105 mg fenofibric acid (Fibricor™)tablet administered 30 minutes after the initiation of a standard breakfast. arm 2: 1 x 145 mg fenofibrate (Tricor®) tablet administered 30 minutes after the initiation of a standard breakfast.

Interventions: intervention 1: Fenofibric Acid (Fibricor™) 105 mg Tablet intervention 2: Fenofibrate (Tricor®) 145 mg Tablet
Intervention descriptions: intervention 1: 1 x 105 mg fenofibric acid (Fibricor™) tablet administered 30 minutes after the initiation of a standard breakfast. intervention 2: 1 x 145 mg Fenofibrate (Tricor®) tablet administered 30 minutes after the start of a standard breakfast.

Protocol document: