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NCT03978403 · ClinicalTrials.gov registry record · Phase 1
A Four-way Crossover Study of 3 Formulations of M207 With Intranasal Zolmitriptan in Healthy Volunteers
A Phase 1 study, sponsored by Zosano Pharma Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03978403: Completed Phase 1 study, sponsored by Zosano Pharma Corporation.
NCT03978403 is a Phase 1 study that has completed, run by Zosano Pharma Corporation. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03978403, a Phase 1 study, has completed, sponsored by Zosano Pharma Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a single-center, open-label, randomized, four-way crossover study. Subjects will receive the four study treatments once, followed by in-clinic monitoring and extensive pharmacokinetic analysis. Dosing occurs \~48 hours apart from patch application, in randomized order. Subjects will have final assessment and be dismissed from the study.
Primary Outcome
maximum observed plasma concentration
Interventions
- DRUG M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches)
- DRUG M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups)
- DRUG M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups
- DRUG Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-05-29 |
| Est. Completion | 2019-06-28 |
| Phase | Phase 1 |
What the finished NCT03978403 record still lists
NCT03978403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 4 interventions - of which M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches) is the first listed.
NCT03978403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03978403 about?
NCT03978403 is a clinical study titled "A Four-way Crossover Study of 3 Formulations of M207 With Intranasal Zolmitriptan in Healthy Volunteers". This is a single-center, open-label, randomized, four-way crossover study. Subjects will receive the four study treatments once, followed by in-clinic monitoring and extensive pharmacokinetic analysis. Dosing occurs \~48 hours apart from patch application, in randomized order. Subjects will have fin...
What is the current status of trial NCT03978403?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-05-29. Estimated completion is 2019-06-28.
What interventions are being tested in trial NCT03978403?
The interventions under investigation include: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches) (DRUG), M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups) (DRUG), M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups (DRUG), Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose (DRUG).
Who is sponsoring clinical trial NCT03978403?
This trial is sponsored by Zosano Pharma Corporation, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03978403's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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