MedTrace Logo

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

NCT00546650 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-02-03

No results posted yet for this study

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

DRUG

Sumatriptan succinate

NP101 iontophoretic transdermal system

DRUG

Sumatriptan succinate

oral, subcutaneous, and intranasal formulations

Sponsors & Collaborators

  • NuPathe Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas C Marbury, MD · Orlando Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2007-12-31
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00546650 on ClinicalTrials.gov