Fenofibrate Bioequivalence Study

This study has been completed.

Study NCT00928694 Information provided by Merck

First Received on June 25, 2009. Last Updated on April 21, 2010 History of Changes

Results First Received: November 10, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Dyslipidemia
Interventions:	Drug: fenofibrate (U.S. formulation) Drug: fenofibrate (UK formulation)

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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

Participant Flow for 2 periods

Period 1: First Intervention

	TRICOR™ First, Then SUPRALIP™	SUPRALIP™ First, Then TRICOR™
STARTED	7	7
COMPLETED	7	7
NOT COMPLETED	0	0

Period 2: Second Intervention

	TRICOR™ First, Then SUPRALIP™	SUPRALIP™ First, Then TRICOR™
STARTED	7	7
COMPLETED	7	7
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
All Participants	No text entered.

Baseline Measures

	All Participants
Number of Participants [units: participants]	14
Age [units: years] Mean ( Full Range )	36.7 ( 23 to 45 )
Gender [units: participants]
Female	5
Male	9
Height [units: Centimeters] Mean ( Full Range )	169.64 ( 154.94 to 187.96 )
Weight [units: Kilograms] Mean ( Full Range )	73.94 ( 51.71 to 93.90 )

Outcome Measures

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1. Primary:

Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid [ Time Frame: Predose and up to 168 hours postdose ]

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2. Primary:

Maximum Plasma Concentration (Cmax) of Fenofibric Acid [ Time Frame: Predose and up to 168 hours postdose ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00928694 History of Changes
Other Study ID Numbers:	2009_606, MK0767-031
Study First Received:	June 25, 2009
Results First Received:	November 10, 2009
Last Updated:	April 21, 2010
Health Authority:	United States: Food and Drug Administration