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MK0524A Bioequivalence Study (0524A-059)

NCT ID: NCT00944645

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

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-01-31

Brief Summary

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

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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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A

MK0524A Source 1 (Phase III manufacturing site)

Group Type ACTIVE_COMPARATOR

niacin (+) laropiprant (Source 1)

Intervention Type DRUG

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

B

MK0524A Source 2 (commercial manufacturing site)

Group Type ACTIVE_COMPARATOR

Comparator: niacin (+) laropiprant (Source 2)

Intervention Type DRUG

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

Interventions

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niacin (+) laropiprant (Source 1)

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

Intervention Type DRUG

Comparator: niacin (+) laropiprant (Source 2)

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

Intervention Type DRUG

Eligibility Criteria

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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
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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MK0524A-059

Identifier Type: -

Identifier Source: secondary_id

2009_613

Identifier Type: -

Identifier Source: secondary_id

0524A-059

Identifier Type: -

Identifier Source: org_study_id

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