MK0524A Bioequivalence Study (0524A-059)

Merck Sharp & Dohme LLC188 enrolled

Overview

This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

188

Conditions

Dyslipidemia

Interventions

niacin (+) laropiprant (Source 1)DRUG

Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods.

Comparator: niacin (+) laropiprant (Source 2)DRUG

Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Maximum Plasma Concentration (Cmax) of Nicotinuric Acid

Measure of rate of absorption of ER niacin

Time frame: Predose and up to 24 hours postdose

Total Amount of Urinary Excretion of Niacin and Its Metabolites

Measure of extent of absorption of ER niacin

Time frame: Predose and up to 96 hours postdose

Area Under Curve (AUC 0-infinity) of Laropiprant

Measure of extent of absorption of laropiprant

Time frame: Predose and up to 48 hours postdose

Maximum Concentration (Cmax) of Laropiprant

Measure of rate of absorption of laropiprant

Time frame: Predose and up to 48 hours postdose

Data from ClinicalTrials.gov

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