Trials / Completed
CompletedNCT03972462
NPC-12G Gel 0.2% Sirolimus PK Bridging Study
Open-label, Fixed-sequence, Two-period Comparative Bioavailability Study of Sirolimus From Topical Application of NPC-12G Gel to Oral Rapamune® Following Single Administration in Healthy Subjects Under Fasting Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Nobelpharma · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NPC-12G Gel 0.2% | Period 1 |
| DRUG | Rapamune® 2 mg tablet | Period 2 |
Timeline
- Start date
- 2019-05-31
- Primary completion
- 2019-06-17
- Completion
- 2019-06-17
- First posted
- 2019-06-03
- Last updated
- 2020-03-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03972462. Inclusion in this directory is not an endorsement.