MK0524A Bioequivalence Study (0524A-059)

Phase 1

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: niacin (+) laropiprant (Source 1)

• Registration Number: NCT00944645
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Results First Submitted: 2009-10-20
• Results First Submitted QC: 2009-10-20
• Results First Posted: 2009-11-25
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-25
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

• Subject is in good health
• Subject is willing to follow all study guidelines

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	niacin (+) laropiprant (Source 1)	MK0524A Source 1 (Phase III manufacturing site)

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of Nicotinuric Acid	Predose and up to 24 hours postdose	Measure of rate of absorption of ER niacin
Total Amount of Urinary Excretion of Niacin and Its Metabolites	Predose and up to 96 hours postdose	Measure of extent of absorption of ER niacin
Area Under Curve (AUC 0-infinity) of Laropiprant	Predose and up to 48 hours postdose	Measure of extent of absorption of laropiprant
Maximum Concentration (Cmax) of Laropiprant	Predose and up to 48 hours postdose	Measure of rate of absorption of laropiprant