Bioequivalence of the Tablet and Liquid-Filled Capsule Forms of MK0974 (0974-042)

NCT ID: NCT00966030

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

50 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 demonstrate the definitive bioequivalence of a solid dose formulation of MK0974 to the liquid filled capsule formulation 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 Tablet

Group Type EXPERIMENTAL

MK0974 tablet

Intervention Type DRUG

MK0974 280 mg tablet in one of two treatment periods

2

MK0974 Liquid filled capsule

Group Type ACTIVE_COMPARATOR

Comparator: MK0974 liquid filled capsule

Intervention Type DRUG

MK0974 300 mg liquid filled capsule in one of two treatment periods

Interventions

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MK0974 tablet

MK0974 280 mg tablet in one of two treatment periods

Intervention Type DRUG

Comparator: MK0974 liquid filled capsule

MK0974 300 mg liquid filled capsule 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 nonsmoker
* Subject is willing to comply with the study restrictions

Exclusion Criteria

* Subject has history of stroke, chronic seizures, or any major neurological disorder
* Subject has a history of cancer
* Subject is a nursing mother
* Subject has uncontrolled high blood pressure
* Subject has or has a history of any disease or condition that might made participation in the study unsafe or confound the study results
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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MK0974-042

Identifier Type: -

Identifier Source: secondary_id

2009_649

Identifier Type: -

Identifier Source: secondary_id

0974-042

Identifier Type: -

Identifier Source: org_study_id

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