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

NCT01381796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2017-10-12

No results posted yet for this study

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

DRUG

NP101

comparison of NP101 with minor patch modifications

DRUG

sumatriptan succinate

tablet, 100 mg

Sponsors & Collaborators

  • NuPathe Inc.

    lead INDUSTRY

Principal Investigators

  • Shannon Canas, MD · Prism Research LLC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-09-30
Completion
2010-09-30

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 NCT01381796 on ClinicalTrials.gov