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NCT00546650 · ClinicalTrials.gov registry record · Phase 1
Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex®
A Phase 1 study of Healthy, sponsored by NuPathe.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00546650: Completed Phase 1 study of Healthy, sponsored by NuPathe.
NCT00546650 is a Phase 1 study of Healthy that has completed, run by NuPathe. The registered enrollment target is 25 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00546650, a Phase 1 study of Healthy, has completed, sponsored by NuPathe.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary objective was to compare the pharmacokinetics (PK) of NP101 (sumatriptan iontophoretic transdermal patch) with the currently approved oral, subcutaneous injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection.
Conditions Studied
Interventions
- DRUG Sumatriptan succinate
Study Locations (1)
Florida
- Orlando Clinical Research Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-03 |
| Phase | Phase 1 |
What the finished NCT00546650 record still lists
NCT00546650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Sumatriptan succinate is the first listed.
NCT00546650 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00546650 about?
NCT00546650 is a clinical study titled "Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex®". 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...
What is the current status of trial NCT00546650?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2007-11. Estimated completion is 2008-03.
What conditions does trial NCT00546650 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00546650?
The interventions under investigation include: Sumatriptan succinate (DRUG).
Who is sponsoring clinical trial NCT00546650?
This trial is sponsored by NuPathe, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00546650 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00546650's enrollment target sits among peer trials
25 778th of 1090 higher than 301 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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