Study of PK, Safety, and Tolerability of 2 Lots of M207 & Intranasal Zolmitriptan in Healthy Volunteers
Public ClinicalTrials.gov record NCT04969497. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Open-Label Three-Way Crossover Study to Compare the Pharmacokinetics, Safety, and Tolerability of Two Lots of M207 3.8 mg (Administered as Two 1.9 mg Patches on the Upper Arm for 30 Minutes) and Intranasal Zolmitriptan 5.0 mg x 2 Doses in Healthy Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a single-center, open-label, randomized, 3-way crossover study. Each subject will receive each of the three study treatments once, followed by in-clinic monitoring and extensive blood sample collection for plasma PK analysis. Dosing will occur at least 48 hours apart from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. After completion dosing, subjects will be assessed one final time.
Study identification
- NCT ID
- NCT04969497
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 23, 2021
- Primary completion
- Sep 1, 2021
- Completion
- Sep 1, 2021
- Last update posted
- Sep 16, 2021
2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Worldwide Clinical Trials | San Antonio | Texas | 78217 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04969497, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 16, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04969497 live on ClinicalTrials.gov.