MK0524B Bioequivalence Study (0524B-070)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: MK0524A (ER niacin + laropiprant); Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin); Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00943124

MK0524B-070

0524B-070

2009_612

Details and patient eligibility

About

This study will evaluate:

1. the bioequivalence of simvastatin and simvastatin acid following dose of simvastatin (ZOCOR™) given together with one tablet of MK0524A or as a component of the triple combination tablet MK0524B.
2. the bioequivalence of laropiprant and ER niacin when administered as the triple combination tablet MK0524B or as the double combination tablet MK0524A given together with simvastatin.

Enrollment: 220 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

220 participants in 2 patient groups

MK0524B then Simvastatin + MK0524A

Experimental group

Description:

Period 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.

Treatment:

Drug: Simvastatin

Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin)

Drug: MK0524A (ER niacin + laropiprant)

Simvastatin + MK0524A then MK0524B

Experimental group

Description:

Period 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).

Treatment:

Drug: Simvastatin

Drug: MK0524B (ER niacin (+) laropiprant (+) simvastatin)

Drug: MK0524A (ER niacin + laropiprant)