---
title: Bioequivalence of Two Tablet Forms of MK0974 (0974-045)
nct_id: NCT00965887
overall_status: COMPLETED
phase: PHASE1
sponsor: Merck Sharp & Dohme LLC
study_type: INTERVENTIONAL
primary_condition: Migraine
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00965887.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00965887"
ct_last_update_post_date: 2015-07-07
last_seen_at: "2026-05-12T07:25:43.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Bioequivalence of Two Tablet Forms of MK0974 (0974-045)

**Official Title:** 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

**NCT ID:** [NCT00965887](https://clinicaltrials.gov/study/NCT00965887)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 36
- **Lead Sponsor:** Merck Sharp & Dohme LLC
- **Conditions:** Migraine
- **Start Date:** 2008-03
- **Completion Date:** 2008-05
- **CT.gov Last Update:** 2015-07-07

## Brief Summary

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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **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
```

## Arms

- **1** (ACTIVE_COMPARATOR) — MK0974 Ethanolate
- **2** (ACTIVE_COMPARATOR) — MK0974 Hydrate

## Interventions

- **MK0974 Ethanolate formulation** (DRUG) — Single dose MK0974 280 mg tablet in one of two treatment periods
- **Comparator: MK0974 Hydrate formulation** (DRUG) — Single dose MK0974 280 mg tablet in one of two treatment periods

## Primary Outcomes

- **Area under the curve (AUC(0 to infinity) following single dose administration of MK0974 ethanolate or hydrate formulations** _(time frame: Through 48 hours postdose)_
- **Peak plasma concentration (Cmax) following single dose administration of MK0974 ethanolate or hydrate formulations** _(time frame: Through 48 Hours Post Dose)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00965887.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00965887*  
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