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fenofibrate

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00928694Fenofibrate Bioequivalence Study (0767-031)PHASE1 COMPLETED 14Feb 1, 2003Apr 1, 2004Aug 19, 2015 -
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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 — 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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