Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00546650 | Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex® | PHASE1 | COMPLETED | 25 | — | — | Nov 1, 2007 | Mar 1, 2008 | Feb 3, 2016 | 1 | United States |
| NCT00846885 | Sumatriptan Succinate 100 mg Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 28 | — | — | Aug 1, 2004 | Oct 1, 2004 | Sep 11, 2009 | 1 | United States |
| NCT00847405 | Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 28 | — | — | Mar 1, 2003 | Mar 1, 2003 | Sep 11, 2009 | 1 | Canada |
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.
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| 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). |
| 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. |
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Sumatriptan succinate | DRUG | NP101 iontophoretic transdermal system |
| Imitrex® | DRUG | 100 mg Tablet |
Inclusion Criteria: * Healthy men or women aged 18 to 65 years. * Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the study, and must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 for al...