MK0524A Bioequivalence Study (0524A-059)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: Comparator: niacin (+) laropiprant (Source 2); Drug: niacin (+) laropiprant (Source 1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00944645

0524A-059

2009_613

MK0524A-059

Details and patient eligibility

About

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

Enrollment: 188 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

A

Active Comparator group

Description:

MK0524A Source 1 (Phase III manufacturing site)

Treatment:

Drug: niacin (+) laropiprant (Source 1)

B

Active Comparator group

Description:

MK0524A Source 2 (commercial manufacturing site)

Treatment:

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