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fenofibrate

Phase 1

Dyslipidemia | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Aug 19, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

fenofibrate · 1 trial · 1 indication

Phase 1 1
NCT00928694Fenofibrate Bioequivalence Study (0767-031)Dyslipidemia
COMPLETED14 Analytics
PHASE1COMPLETED
Fenofibrate Bioequivalence Study (0767-031)
DyslipidemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORFenofibrate U.S. Formulation
2ACTIVE_COMPARATORFenofibrate UK Formulation

Interventions

NameTypeDescription
fenofibrate (U.S. formulation)DRUGSingle dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.
fenofibrate (UK formulation)DRUGSingle dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Subject is in good health * Subject is willing to follow all study guidelines Exclusion Criteria: * 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 ...

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Frequently asked questions about fenofibrate

What is fenofibrate used for?

Fenofibrate is a small molecule used for dyslipidemia, a condition characterized by abnormal levels of lipids in the blood. It is being developed by Merck & Company, Inc. (MRK) as a potential treatment for this cardiovascular condition.

Who makes fenofibrate?

Fenofibrate is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical research on this small molecule for the treatment of dyslipidemia.

What phase is fenofibrate in?

Fenofibrate is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development.

What clinical trials is fenofibrate in?

Fenofibrate has one completed Phase 1 clinical trial, identified as NCT00928694, titled "Fenofibrate Bioequivalence Study (0767-031)". This trial enrolled 14 participants with dyslipidemia and was active-controlled, though it was not double-blinded.

Is fenofibrate the same as other drugs?

Fenofibrate is a distinct drug entity. It is not known to be the same as any other drug under a different name. It is being studied specifically for its effects on dyslipidemia in a Phase 1 clinical trial.