NCT00723983

Phase I, Open Label, Single-Dose, Four Way Crossover Study to Compare the PK of NP101 With Oral Imitrex® (50mg) in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period

A Phase I, Open Label, Single-Dose, Four-Way Crossover Study Comparing the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) With an Oral Formulation of Imitrex® (50mg) in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: NuPathe Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To compare the pharmacokinetics of NP101 with a currently approved oral formulation of Imitrex® (50 mg) in migraine subjects both during an acute migraine attack and during a non-migraine period.

Conditions

• Migraine Disorders

Interventions

Type	Name	Description
DRUG	Sumatriptan succinate	Sumatriptan succinate 50 mg taken orally
DRUG	NP101 Study Patch	NP101 study patch 4 hour application

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-07-29
• Last updated: 2016-02-03

Locations

1 site across 1 country: United States