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NCT00546650
A Phase I, Single Center, Open Label, Randomized, Single-Dose, Five-Way Crossover Study to Compare the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex® in Healthy Volunteers
Phase 1 trial testing Sumatriptan succinate in Healthy in 25 participants. Completed in 1 March 2008.
1 December 2007
Quick facts
| Lead sponsor | NuPathe Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 1 November 2007 |
| Primary completion | 1 December 2007 |
| Estimated completion | 1 March 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sumatriptan succinate — full drug profile →
- Sumatriptan succinate — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
NuPathe Inc. — full company profile →
Who can join
Adults 18 to 65, any sex, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pharmacokinetics
Time frame: Blood samples to be drawn at pre-dose (within 15 minutes prior to dosing) and at 0.25, 0.50, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 16 hrs post dose.
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00546650
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00546650 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NuPathe Inc.
- Last refreshed: 2 February 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00546650.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing