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NCT01381796 · ClinicalTrials.gov registry record · Phase 1
Compare PK and Bioavailability of 2 NP101 Patches With Oral Imitrex in Healthy Adults
A Phase 1 study, sponsored by NuPathe.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
NCT01381796: Completed Phase 1 study, sponsored by NuPathe.
NCT01381796 is a Phase 1 study that has completed, run by NuPathe. The registered enrollment target is 63 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01381796, a Phase 1 study, has completed, sponsored by NuPathe.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
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)
Primary Outcome
Blood samples (4 mL per sample) for PK analysis will be collected at the following times for the determination of sumatriptan concentrations in plasma for each treatment: Pre-dose (within 15 minutes prior to dosing) and at 0.25, 0.50, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post-dose.
Interventions
- DRUG NP101
- DRUG sumatriptan succinate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
What the finished NCT01381796 record still lists
NCT01381796 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which NP101 is the first listed.
NCT01381796 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01381796 about?
NCT01381796 is a clinical study titled "Compare PK and Bioavailability of 2 NP101 Patches With Oral Imitrex in Healthy Adults". 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. Collec...
What is the current status of trial NCT01381796?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2009-12. Estimated completion is 2010-09.
What interventions are being tested in trial NCT01381796?
The interventions under investigation include: NP101 (DRUG), sumatriptan succinate (DRUG).
Who is sponsoring clinical trial NCT01381796?
This trial is sponsored by NuPathe, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01381796's enrollment target sits among peer trials
63 820th of 2000 higher than 1,177 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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