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This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPC-12G Gel 0.2% (Period 1) | Experimental | A single 800 mg quantity weight (1.6 mg sirolimus) dose will be applied to the central face on Day 1. |
|
| Rapamune Tablet (Period 2) | Active Comparator | Rapamune® (sirolimus) 2 mg tablet for oral dosing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPC-12G Gel 0.2% | Drug | Period 1 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-48 | Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose | |
| Cmax | Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose | |
| Tmax | Sampling: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 hours post-dose |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InVentiv Health Clinical Research Services LLC | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D005782 | Gels |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003102 | Colloids |
| D045424 |
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| Rapamune® 2 mg tablet | Drug | Period 2 |
|
|
| Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |