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Phase I Open Label Single-Dose Study to Compare the Pharmacokinetics of NP101 Healthy Volunteers

NCT00720018 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2016-02-03

No results posted yet for this study

Summary

The primary objective is to compare the pharmacokinetics (PK) profiles among five NP101 patches in healthy volunteers.

The secondary objective is to evaluate the safety of NP101 in healthy volunteers.

Conditions

  • Migraine Disorders

Interventions

DRUG

NP101 Sumatriptan Iontophoretic Transdermal Patch

NP101 transdermal patch delivering sumatriptan for 4 hours.

Sponsors & Collaborators

  • NuPathe Inc.

    lead INDUSTRY

Principal Investigators

  • Shannon M Canas, MD · Prism Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

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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 NCT00720018 on ClinicalTrials.gov