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Bioavailability Study to Compare OPTINOSE SUMATRIPTAN With IMITREX® in Healthy Subjects

NCT01507610 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-02-29

No results posted yet for this study

Summary

The purpose of this study is:

* To compare the single-dose pharmacokinetics (PK) of intranasal administration of 20 mg OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects.
* To estimate the relative bioavailability of single-dose intranasal administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX® (sumatriptan) Oral Tablet compared to a single-dose of 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects.

Conditions

Interventions

DRUG

Sumatriptan

To compare the single-dose pharmacokinetics (PK) and relative bioavailability of intranasal administration of 20 mg OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects.

Sponsors & Collaborators

  • Optinose US Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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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 NCT01507610 on ClinicalTrials.gov