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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Migraine

Treatments: Drug: MK0974 tablet; Drug: Comparator: MK0974 liquid filled capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT00966030

2009_649

MK0974-042

0974-042

Details and patient eligibility

About

This study will demonstrate the definitive bioequivalence of a solid dose formulation of MK0974 to the liquid filled capsule formulation of MK0974.

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Experimental group

Description:

MK0974 Tablet

Treatment:

Drug: MK0974 tablet

2

Active Comparator group

Description:

MK0974 Liquid filled capsule

Treatment:

Drug: Comparator: MK0974 liquid filled capsule