Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mutual Pharmaceutical Company, Inc.

ClinicalTrials.gov Identifier:

NCT00961259

First received: August 14, 2009

Last updated: June 1, 2012

Last verified: June 2012

History of Changes

Results First Received: August 20, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Basic Science
Condition:	Healthy
Interventions:	Drug: Fenofibric Acid 35 mg Tablet Drug: Fenofibric Acid 105 mg Tablet

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Fifty-Four (54) non-obese, non-smoking, healthy adult volunteers from the community at large were enrolled.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One hundred and eight (108) subjects were screened. Thirty-six (36) subjects were screen failures. Of the remaining seventy-two (72) subjects, fifty-six (56) checked in and fifty-four (54) were enrolled.

Reporting Groups

	Description
Treatment Sequence ABC	On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (treatment B). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C).
Treatment Sequence BCA	On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A).
Treatment Sequence CAB	On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B).

Participant Flow for 5 periods

Period 1: First Intervention

	Treatment Sequence ABC	Treatment Sequence BCA	Treatment Sequence CAB
STARTED	18	18	18
COMPLETED	18	18	18
NOT COMPLETED	0	0	0

Period 2: Washout Period of 7 Days

	Treatment Sequence ABC	Treatment Sequence BCA	Treatment Sequence CAB
STARTED	18	18	18
COMPLETED	18	17 ^[1]	18
NOT COMPLETED	0	1	0
due to concomitant medication used	0	1	0

[1]	dropped due to concomitant medication used prior to admission.

Period 3: Second Intervention

	Treatment Sequence ABC	Treatment Sequence BCA	Treatment Sequence CAB
STARTED	18	17	18
COMPLETED	18	17	18
NOT COMPLETED	0	0	0

Period 4: Washout Period of 7 Days

	Treatment Sequence ABC	Treatment Sequence BCA	Treatment Sequence CAB
STARTED	18	17	18
COMPLETED	18	17	18
NOT COMPLETED	0	0	0

Period 5: Third Intervention

	Treatment Sequence ABC	Treatment Sequence BCA	Treatment Sequence CAB
STARTED	18	17	18
COMPLETED	18	17	18
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Fenofibric Acid - Treatments A, B and C	All subjects received each of the three study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8 and 15 each subject received either one 35 mg fenofibric acid tablet (treatment A), three 35 mg fenofibric acid tablets (105 mg total dose, treatment B) or one 105 mg fenofibric acid tablet (treatment C).

Baseline Measures

	Fenofibric Acid - Treatments A, B and C
Number of Participants [units: participants]	54
Age [units: participants]
<=18 years	0
Between 18 and 65 years	54
>=65 years	0
Age [units: years] Mean ± Standard Deviation	24.46 ± 7.10
Gender [units: participants]
Female	18
Male	36
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	3
Not Hispanic or Latino	51
Unknown or Not Reported	0
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	2
Asian	2
Native Hawaiian or Other Pacific Islander	0
Black or African American	4
White	46
More than one race	0
Unknown or Not Reported	0

Outcome Measures

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1. Primary:

Maximum Plasma Concentration (Cmax) [ Time Frame: 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 ]

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2. Primary:

Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] [ Time Frame: 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 ]

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3. Primary:

The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞) [ Time Frame: 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. ]

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Serious Adverse Events

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Other Adverse Events

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