Bioequivalence of Two Tablet Forms of MK0974 (0974-045)

NCT ID: NCT00965887

Last Updated: 2015-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-05-31

Brief Summary

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This study will evaluate the bioequivalence of two solid dose formulations of MK0974.

Detailed Description

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Conditions

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Migraine

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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1

MK0974 Ethanolate

Group Type ACTIVE_COMPARATOR

MK0974 Ethanolate formulation

Intervention Type DRUG

Single dose MK0974 280 mg tablet in one of two treatment periods

2

MK0974 Hydrate

Group Type ACTIVE_COMPARATOR

Comparator: MK0974 Hydrate formulation

Intervention Type DRUG

Single dose MK0974 280 mg tablet in one of two treatment periods

Interventions

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MK0974 Ethanolate formulation

Single dose MK0974 280 mg tablet in one of two treatment periods

Intervention Type DRUG

Comparator: MK0974 Hydrate formulation

Single dose MK0974 280 mg tablet in one of two treatment periods

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject is in good health
* Subject is a non-smoker
* Subject is willing to comply with the study restrictions

Exclusion Criteria

* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of cancer
* Subject is a nursing mother
* Subject has or has a history of any disease or condition that might make participation in the study unsafe or that might confound the results of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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MK0974-045

Identifier Type: -

Identifier Source: secondary_id

2009_650

Identifier Type: -

Identifier Source: secondary_id

0974-045

Identifier Type: -

Identifier Source: org_study_id

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