Trials Sponsors Conditions Drugs Pricing

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (2)

Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid
Predose and up to 168 hours postdose
Maximum Plasma Concentration (Cmax) of Fenofibric Acid
Predose and up to 168 hours postdose

Study Arms (2)

1

ACTIVE COMPARATOR

Fenofibrate U.S. Formulation

Drug: fenofibrate (U.S. formulation)

2

ACTIVE COMPARATOR

Fenofibrate UK Formulation

Drug: fenofibrate (UK formulation)

Interventions

fenofibrate (U.S. formulation)Drug

Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.

Also known as: Tricor®

fenofibrate (UK formulation)Drug

Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.

Also known as:

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Subject is in good health
Subject is willing to follow all study guidelines

You may not qualify if:

Sponsors & Collaborators

Merck Sharp & Dohme LLC
Industrylead

MeSH Terms

Conditions

Dyslipidemias

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthers

Results Point of Contact

Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.

Study Officials

Medical Monitor
Merck Sharp & Dohme LLC
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

14 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 26, 2009

Study Start

February 2003

Date type not reported

This date has not been verified as actual or estimated.

Fenofibrate Bioequivalence Study (0767-031)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record