NPC-12G Gel 0.2% Sirolimus PK Bridging Study
Phase 1
Completed
- Conditions
- Bioavailability Study
- Interventions
- Drug: NPC-12G Gel 0.2%
- Registration Number
- NCT03972462
- Lead Sponsor
- Nobelpharma
- Brief Summary
This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description NPC-12G Gel 0.2% (Period 1) NPC-12G Gel 0.2% 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) Rapamune® 2 mg tablet Rapamune® (sirolimus) 2 mg tablet for oral dosing.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
InVentiv Health Clinical Research Services LLC
🇺🇸Miami, Florida, United States