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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Migraine

Treatments: Drug: MK0974 Ethanolate formulation; Drug: Comparator: MK0974 Hydrate formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00965887

MK0974-045

2009_650

0974-045

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

1

Active Comparator group

Description:

MK0974 Ethanolate

Treatment:

Drug: MK0974 Ethanolate formulation

2

Active Comparator group

Description:

MK0974 Hydrate

Treatment:

Drug: Comparator: MK0974 Hydrate formulation