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The purpose of this research is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A - NP101 | Active Comparator |
| |
| Treatment C - oral sumatriptan succinate | Active Comparator |
| |
| Treatment B - NP101B | Experimental |
| |
| Treatment D - NP101D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NP101 | Drug | comparison of NP101 with minor patch modifications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of variance (ANOVA) will be used to compare AUC0-inf and Cmax values between treatments. AUC0-last, Tmax and t1/2 will be summarized descriptively. | Blood samples (4 mL per sample) for PK analysis will be collected at the following times for the determination of sumatriptan concentrations in plasma for each treatment: Pre-dose (within 15 minutes prior to dosing) and at 0.25, 0.50, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post-dose. | Blood samples (4 mL per sample) for PK analysis will be collected for all treatments by catheter or venipuncture into EDTA collection tubes for the determination of sumatriptan concentrations in plasma for each treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon Canas, MD | Prism Research LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prism Research, LLC | Saint Paul | Minnesota | 55114 | United States |
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| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| sumatriptan succinate | Drug | tablet, 100 mg |
|
|
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |