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

An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Bioequivalence of a Single Dose of a Tablet Form of MK0974 Ethanolate vs. a Single Dose of a Tablet Form of MK0974 Hydrate in Healthy Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00965887
Enrollment
36
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 evaluate the bioequivalence of two solid dose formulations of MK0974.

Interventions

DRUGMK0974 Ethanolate formulation

Single dose MK0974 280 mg tablet in one of two treatment periods

DRUGComparator: MK0974 Hydrate formulation

Single dose MK0974 280 mg tablet in one of two treatment periods

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

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 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

Design outcomes

Primary

MeasureTime frame
Area under the curve (AUC(0 to infinity) following single dose administration of MK0974 ethanolate or hydrate formulationsThrough 48 hours postdose
Peak plasma concentration (Cmax) following single dose administration of MK0974 ethanolate or hydrate formulationsThrough 48 Hours Post Dose

Outcome results

None listed

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