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

An Open-Label, Randomized, 2-Period Crossover Study to Demonstrate the Definitive Bioequivalence of a Single Dose of a Tablet Form of MK0974 Ethanolate Vs. a Single Dose of the Reference MK0974 Liquid Filled Capsule in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00966030

Enrollment

Registered

2009-08-26

Start date

2008-03-31

Completion date

2008-05-31

Last updated

2015-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Brief summary

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

Interventions

DRUGMK0974 tablet

MK0974 280 mg tablet in one of two treatment periods

DRUGComparator: MK0974 liquid filled capsule

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026