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A Four-way Crossover Study of 3 Formulations of M207 With Intranasal Zolmitriptan in Healthy Volunteers

NCT03978403 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-11-18

Study results available
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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.

Conditions

Interventions

DRUG

M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches)

M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "Sled" coater and packaged in foil pouches

DRUG

M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups)

M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "MACAP" coater and packaged in foil cups

DRUG

M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups

M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "miniMac" coater and packaged in foil pouches

DRUG

Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose

Zolmitriptan 2.5 mg/0.1 mL nasal spray \[ZOMIG\] single dose

Sponsors & Collaborators

  • Zosano Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Don Kellerman, PharmD · Zosano Pharma Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-29
Primary Completion
2019-06-28
Completion
2019-06-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978403 on ClinicalTrials.gov