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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | NP101 Patch |
|
| Period 2 | Experimental | NP101 Patch |
|
| Period 3 | Experimental | NP101 Patch |
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| Period 4 | Experimental | NP101 Patch |
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| Period 5 | Experimental | NP101 Patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NP101 Sumatriptan Iontophoretic Transdermal Patch | Drug | NP101 transdermal patch delivering sumatriptan for 4 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective was to compare the pharmacokinetics (PK) profiles among five NP101 patches in healthy volunteers. | Blood samples were collected at time points: 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon M Canas, MD | Prism Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prism Research | Saint Paul | Minnesota | 55114 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |