Trial Outcomes & Findings for Fenofibrate Bioequivalence Study (0767-031) (NCT NCT00928694)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

Predose and up to 168 hours postdose

Results posted on

2015-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	TRICOR™ First, Then SUPRALIP™ U.S. formulation (TRICOR™) 160 mg tablet/ UK formulation (SUPRALIP™) 160 mg tablet	SUPRALIP™ First, Then TRICOR™ UK formulation (SUPRALIP™) 160 mg tablet / U.S. formulation (TRICOR™) 160 mg tablet
First Intervention STARTED	7	7
First Intervention COMPLETED	7	7
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	7	7
Second Intervention COMPLETED	7	7
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fenofibrate Bioequivalence Study (0767-031)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=14 Participants
Age, Continuous	36.7 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Height	169.64 Centimeters n=5 Participants
Weight	73.94 Kilograms n=5 Participants

PRIMARY outcome

Timeframe: Predose and up to 168 hours postdose

Population: Healthy Male and Female subjects Aged 18 to 45

Outcome measures

Outcome measures
Measure	U.S. Formulation (TRICOR™) n=14 Participants U.S. Formulation: single oral 160 mg dose of the U.S. formulation of fenofibrate with food.	UK Formulation (SUPRALIP™) n=14 Participants UK Formulation: single oral 160 mg dose of the UK formulation of fenofibrate with food.
Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid	116 μg·hr/mL Standard Deviation 35.1	121 μg·hr/mL Standard Deviation 36.4

PRIMARY outcome

Timeframe: Predose and up to 168 hours postdose

Population: Healthy Male and Female subjects Aged 18 to 45

Outcome measures

Outcome measures
Measure	U.S. Formulation (TRICOR™) n=14 Participants U.S. Formulation: single oral 160 mg dose of the U.S. formulation of fenofibrate with food.	UK Formulation (SUPRALIP™) n=14 Participants UK Formulation: single oral 160 mg dose of the UK formulation of fenofibrate with food.
Maximum Plasma Concentration (Cmax) of Fenofibric Acid	6.35 μg/mL Standard Deviation 1.61	6.48 μg/mL Standard Deviation 1.80

Adverse Events

Tricor™

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Supralip™

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tricor™ n=14 participants at risk U.S. formulation (TRICOR™) 160 mg tablet	Supralip™ n=14 participants at risk UK formulation (SUPRALIP™) 160 mg tablet
Gastrointestinal disorders Loose Stools	7.1% 1/14	0.00% 0/14

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER