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MK0524B Bioequivalence Study (0524B-070)

NCT ID: NCT00943124

Last Updated: 2015-06-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2007-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MK0524B then Simvastatin + MK0524A

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.

MK0524A (ER niacin + laropiprant)

Intervention Type DRUG

Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.

Simvastatin

Intervention Type DRUG

Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.

Simvastatin + MK0524A then MK0524B

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).

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.

MK0524A (ER niacin + laropiprant)

Intervention Type DRUG

Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.

Simvastatin

Intervention Type DRUG

Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.

Interventions

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

Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods.

Intervention Type DRUG

MK0524A (ER niacin + laropiprant)

Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods.

Intervention Type DRUG

Simvastatin

Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods.

Intervention Type DRUG

Other Intervention Names

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MK0524B MK0524A Zocor™

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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MK0524B-070

Identifier Type: -

Identifier Source: secondary_id

2009_612

Identifier Type: -

Identifier Source: secondary_id

0524B-070

Identifier Type: -

Identifier Source: org_study_id

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