Fenofibrate Bioequivalence Study (0767-031)
An Open-Label, Randomized, 2-Period, Crossover Study to Determine Definitive Bioequivalence After Administration of Single 160 mg Doses of the U.S. and UK Formulations of Fenofibrate in Healthy Adult Subjects
3 other identifiers
interventional
14
0 countries
N/A
Brief Summary
This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2003
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 25, 2009
CompletedFirst Posted
Study publicly available on registry
June 26, 2009
CompletedResults Posted
Study results publicly available
December 11, 2009
CompletedAugust 19, 2015
August 1, 2015
2 months
June 25, 2009
November 10, 2009
August 18, 2015
Conditions
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 COMPARATORFenofibrate U.S. Formulation
2
ACTIVE COMPARATORFenofibrate UK Formulation
Interventions
Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.
Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.
Eligibility Criteria
You may qualify if:
- Subject is in good health
- Subject is willing to follow all study guidelines
You may not qualify if:
- Subject has uncontrolled high blood pressure, impaired glucose tolerance, diabetes, or other major diseases or chronic conditions that would confound the results of the study or make participation unsafe
- Female subject is receiving oral contraceptives or hormone replacement therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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 1, 2003
Primary Completion
April 1, 2003
Study Completion
April 1, 2004
Last Updated
August 19, 2015
Results First Posted
December 11, 2009
Record last verified: 2015-08