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MK0524B

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment220

FDA Designations

No designations recorded

Clinical trial landscape

MK0524B · 1 trial · 1 indication

Phase 1 1
NCT00943124MK0524B Bioequivalence Study (0524B-070)Dyslipidemia
COMPLETED220 Analytics
PHASE1COMPLETED
MK0524B Bioequivalence Study (0524B-070)
DyslipidemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid
Through 48 Hours Post Dose

Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin

Peak Plasma Concentration (Cmax) of Simvastatin Acid
48 Hours Post Dose

Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin

Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin
Through 48 Hours Post Dose

Plasma Area Under the Curve of simvastatin

Peak Plasma Concentration (Cmax) of Simvastatin
48 Hours Post Dose
Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant
48 Hours Post Dose

Plasma Area Under the Curve of Laropiprant

Peak Plasma Concentration (Cmax) of Laropiprant
48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Nicotinuric Acid
24 Hours Post Dose

Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin

Total Urinary Excretion of Niacin and Its Metabolites
96 Hours Post Dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK0524B then Simvastatin + MK0524AEXPERIMENTALPeriod 1: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg). Period 2: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets.
Simvastatin + MK0524A then MK0524BEXPERIMENTALPeriod 1: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets. Period 2: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg).

Interventions

NameTypeDescription
MK0524B (ER niacin (+) laropiprant (+) simvastatin)DRUGSingle dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.
MK0524A (ER niacin + laropiprant)DRUGSingle dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.
SimvastatinDRUGSingle dose simvastatin (Zocor™) 20 mg in one of two treatment periods.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Subject is in good health * Subject is a nonsmoker * Subject is willing to follow the study guidelines Exclusion Criteria: * Subject has or has a history of any illness that might confound the results of the study or make participation in the study unsafe for the subject

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