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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 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. |
|
| B | Active Comparator | Sumatriptan succinate (Imitrex®) tablet: 100 mg orally. |
|
| C | Active Comparator | Sumatriptan succinate (Imitrex®) injection: 6 mg subcutaneously (SQ). |
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| D | Active Comparator | Sumatriptan (Imitrex®) nasal spray: 20 mg (one spray) intranasal (IN) into one nostril. |
|
| E | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sumatriptan succinate | Drug | NP101 iontophoretic transdermal system |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | The primary objective was to compare the pharmacokinetics (PK) of NP101 (sumatriptan iontophoretic transdermal patch) with the currently approved oral, subcutaneous injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection. | Blood samples to be drawn at 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 |
|---|---|---|
| Thomas C Marbury, MD | Orlando Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | 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 |
oral, subcutaneous, and intranasal formulations |
|
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |