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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 is a Phase 1 study that has completed, run by Zosano Pharma Corporation. The registered enrollment target is 24 participants.

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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.

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

FieldValue
Enrollment Target 24 participants
Start Date 2019-05-29
Est. Completion 2019-06-28
Phase Phase 1

Sponsor

Zosano Pharma Corporation

7 total trials

What the Registry Record Tells You About NCT03978403

The ClinicalTrials.gov registry entry for NCT03978403 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 M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches) is the first listed.

NCT03978403 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.