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To compare the pharmacokinetics of NP101 with a currently approved oral formulation of Imitrex® (50 mg) in migraine subjects both during an acute migraine attack and during a non-migraine period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Active Comparator | Subject dosed with oral sumatriptan succinate during an acute migraine attack. |
|
| Period 2 | Active Comparator | Subject dosed with oral sumatriptan during a non-migraine period. |
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| Period 3 and Period 6 | Experimental | Subject dosed with NP101 during an acute migraine attack. |
|
| Period 4 and Period 5 | Experimental | Subject dosed with NP101 study patch during a non-migraine period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sumatriptan succinate | Drug | Sumatriptan succinate 50 mg taken orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the pharmacokinetics of NP101 with a currently approved formulation of Imitrex in migraine subjects during an acute migraine attack and during a non-migraine period. | PK samples at pre and 0.25, 0.5, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 10, 12 and 24 hours post each dose/period for Periods 1, 2, 3, and 4 [24 hour PK will not be done for Periods 5 and 6] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerri L Wilks, MD, CPI | MD clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Clinic | Hallandale | Florida | 33009 | United States |
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| NP101 Study Patch |
| Drug |
NP101 study patch 4 hour application |
|
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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