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NCT03708744 · ClinicalTrials.gov registry record · Phase 1
A Study 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
NCT03708744 is a Phase 1 study that has completed, run by Zosano Pharma Corporation. The registered enrollment target is 24 participants.
The verdict
NCT03708744, 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. Each subject will receive each of the four study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis. Dosing will occur approximately 48 hours apart, until completion of dosing in randomized order per the treatment sequence tables. Plasma samples from the dosing days will be sent to the analytical laboratory for analysis and tolerability for each of the dose levels will be summarized. After completion of the four dosing days, subjects will be assessed one final time and dismissed from the study.
Interventions
- DRUG A: M207 3.8mg, 30 min, upper arm
- DRUG B: M207 3.8 mg, 30 min, thigh
- DRUG C: M207 3.8 mg, 1 hr, upper arm
- DRUG D:zolmitriptan nasal spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2018-11-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03708744
The ClinicalTrials.gov registry entry for NCT03708744 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 4 interventions - of which A: M207 3.8mg, 30 min, upper arm is the first listed.
NCT03708744 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03708744 about?
NCT03708744 is a clinical study titled "A Study of M207 With Intranasal Zolmitriptan in Healthy Volunteers". This is a single-center, open-label, randomized, four-way crossover study. Each subject will receive each of the four study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis. Dosing will occur approximately 48 hours apart, until com...
What is the current status of trial NCT03708744?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-11-01. Estimated completion is 2018-11-20.
What interventions are being tested in trial NCT03708744?
The interventions under investigation include: A: M207 3.8mg, 30 min, upper arm (DRUG), B: M207 3.8 mg, 30 min, thigh (DRUG), C: M207 3.8 mg, 1 hr, upper arm (DRUG), D:zolmitriptan nasal spray (DRUG).
Who is sponsoring clinical trial NCT03708744?
This trial is sponsored by Zosano Pharma Corporation, which has 7 total clinical trials registered on ClinicalTrials.gov.
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