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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00546650
The ClinicalTrials.gov registry entry for NCT00546650 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The listed sponsor is NuPathe, which has 7 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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