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| Sponsor: | NuPathe Inc. |
|---|---|
| Information provided by: | NuPathe Inc. |
| ClinicalTrials.gov Identifier: | NCT00546650 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Sumatriptan succinate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 25 |
| Study Start Date: | November 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
NP101 patch applied to the upper arm and left in place for 4 hours. The NP101 patch is designed to deliver ~ 10 mg of sumatriptan utilizing up to 600 mA minutes.
|
Drug: Sumatriptan succinate |
|
Active Comparator: B
Sumatriptan succinate (Imitrex®) tablet: 100 mg orally.
|
Drug: Sumatriptan succinate |
|
Active Comparator: C
Sumatriptan succinate (Imitrex®) injection: 6 mg subcutaneously (SQ).
|
Drug: Sumatriptan succinate |
|
Active Comparator: D
Sumatriptan (Imitrex®) nasal spray: 20 mg (one spray) intranasal (IN) into one nostril.
|
Drug: Sumatriptan succinate |
|
Experimental: E
NP101 patch applied to the upper arm and left in place for 4 hours. The NP101 patch is designed to deliver ~ 10 mg of sumatriptan utilizing up to 600 mA minutes.
|
Drug: Sumatriptan succinate |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Orlando Clinical Research Center | |
| Orlando, Florida, United States, 32809 | |
| Principal Investigator: | Thomas C Marbury, MD | Orlando Clinical Research Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00546650 History of Changes |
| Other Study ID Numbers: | NP101-005 |
| Study First Received: | October 17, 2007 |
| Last Updated: | November 4, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Focus of study is to compare pharmacokinetics |
|
Sumatriptan Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Serotonin 5-HT1 Receptor Agonists |
Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |