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

Phase 1

Completed

• Conditions: Migraine
• Interventions: Drug: MK0974 tablet

• Registration Number: NCT00966030
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-26
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-03
• Last Update Posted: 2015-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	MK0974 tablet	MK0974 Tablet

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC(0 to infinity)) following single dose administration of MK0974 tablet formulation and MK0974 liquid filled capsule formulation	Through 48 Hours Post Dose
Peak plasma concentration (Cmax) following single dose administration of MK0974 tablet formulation and MK0974 liquid filled capsule formulation	Through 48 Hours Post Dose