NCT00546650

Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex®

A Phase I, Single Center, Open Label, Randomized, Single-Dose, Five-Way Crossover Study to Compare the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex® in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: NuPathe Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection. The secondary objective is to evaluate the safety of NP101 in healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sumatriptan succinate	NP101 iontophoretic transdermal system
DRUG	Sumatriptan succinate	oral, subcutaneous, and intranasal formulations

Timeline

• Start date: 2007-11-01
• Primary completion: 2007-12-01
• Completion: 2008-03-01
• First posted: 2007-10-19
• Last updated: 2016-02-03

Locations

1 site across 1 country: United States