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NCT04969497 · ClinicalTrials.gov registry record · Phase 1
Study of PK, Safety, and Tolerability of 2 Lots of M207 & Intranasal Zolmitriptan in Healthy Volunteers
A Phase 1 study, sponsored by Zosano Pharma Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT04969497 is a Phase 1 study that has completed, run by Zosano Pharma Corporation. The registered enrollment target is 48 participants.
The verdict
NCT04969497, a Phase 1 study, has completed, sponsored by Zosano Pharma Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Treatment A: M207 3.8 mg "MiniMac"
- DRUG Treatment B: M207 3.8 mg "MACAP"
- DRUG Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-06-24 |
| Est. Completion | 2021-09-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04969497
The ClinicalTrials.gov registry entry for NCT04969497 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zosano Pharma Corporation, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Treatment A: M207 3.8 mg "MiniMac" is the first listed.
NCT04969497 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04969497 about?
NCT04969497 is a clinical study titled "Study of PK, Safety, and Tolerability of 2 Lots of M207 & Intranasal Zolmitriptan in Healthy Volunteers". 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 ...
What is the current status of trial NCT04969497?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2021-06-24. Estimated completion is 2021-09-02.
What interventions are being tested in trial NCT04969497?
The interventions under investigation include: Treatment A: M207 3.8 mg "MiniMac" (DRUG), Treatment B: M207 3.8 mg "MACAP" (DRUG), Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0 (DRUG).
Who is sponsoring clinical trial NCT04969497?
This trial is sponsored by Zosano Pharma Corporation, which has 7 total clinical trials registered on ClinicalTrials.gov.
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