NCT01507610

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

An Open-Label, Single-Dose, Randomized, Crossover Study to Compare the Bioavailability of the 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Optinose US Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

• Migraine

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-01-11
• Last updated: 2012-02-29

Locations

1 site across 1 country: United States