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Sponsored by: |
NuPathe Inc. |
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Information provided by: | NuPathe Inc. |
ClinicalTrials.gov Identifier: | NCT00720018 |
The primary objective is to compare the pharmacokinetics (PK) profiles among five NP101 patches in healthy volunteers. The secondary objective is to evaluate the safety of NP101 in healthy volunteers.
Condition | Intervention | Phase |
---|---|---|
Migraine Disorders |
Other: NP101 Sumatriptan Iontophoretic Transdermal Patch |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Phase I, Single Center, Open Label, Single-Dose, Five-Period Study to Compare the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) in Healthy Volunteers |
Enrollment: | 4 |
Study Start Date: | June 2008 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Period 1: Experimental
NP101 Patch
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Other: NP101 Sumatriptan Iontophoretic Transdermal Patch
NP101 transdermal patch delivering sumatriptan for 4 hours.
|
Period 2: Experimental
NP101 Patch
|
Other: NP101 Sumatriptan Iontophoretic Transdermal Patch
NP101 transdermal patch delivering sumatriptan for 4 hours.
|
Period 3: Experimental
NP101 Patch
|
Other: NP101 Sumatriptan Iontophoretic Transdermal Patch
NP101 transdermal patch delivering sumatriptan for 4 hours.
|
Period 4: Experimental
NP101 Patch
|
Other: NP101 Sumatriptan Iontophoretic Transdermal Patch
NP101 transdermal patch delivering sumatriptan for 4 hours.
|
Period 5: Experimental
NP101 Patch
|
Other: NP101 Sumatriptan Iontophoretic Transdermal Patch
NP101 transdermal patch delivering sumatriptan for 4 hours.
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | NuPathe ( Mark Pierce, MD, PhD, Chief Scientific Officer ) |
Study ID Numbers: | PROT-15-NP101-006 |
Study First Received: | July 21, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00720018 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Serotonin Agonists Neurotransmitter Agents Central Nervous System Diseases Headache Disorders, Primary Healthy Cardiovascular Agents Brain Diseases |
Serotonin Headache Disorders Sumatriptan Migraine Disorders Headache Vasoconstrictor Agents |
Serotonin Agonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Headache Disorders, Primary Cardiovascular Agents |
Brain Diseases Pharmacologic Actions Headache Disorders Sumatriptan Serotonin Agents Migraine Disorders Therapeutic Uses Vasoconstrictor Agents |