NCT01381796

Compare PK and Bioavailability of 2 NP101 Patches With Oral Imitrex in Healthy Adults

A Phase I, Single Center, Open Label, Randomized, Single-Dose, Three-Way Crossover Study to Compare the Pharmacokinetics and Bioavailability of Two NP101 (Sumatriptan Iontophoretic Transdermal Patch) With an Oral Formulation of Imitrex in Healthy Volunteers and to Collect Resistance Data During Application of NP101

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: NuPathe Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to: 1. Compare two study patches having minor differences in patch components 2. Compare the pharmacokinetics (PK - how the body absorbs, metabolizes and eliminates medication) of NP101 (study patches) versus a currently approved oral formulation of Imitrex 3. Collect resistance data during application of NP101 (study patch)

Conditions

• Compare Bioequivalence Patches Previously Used in the NP101-007 Study

Interventions

Type	Name	Description
DRUG	NP101	comparison of NP101 with minor patch modifications
DRUG	sumatriptan succinate	tablet, 100 mg

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2011-06-27
• Last updated: 2017-10-12

Locations

1 site across 1 country: United States