NPC-12G Gel 0.2% Sirolimus PK Bridging Study
NCT03972462 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2020-03-06
Summary
This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations.
Conditions
- Bioavailability Study
Interventions
- DRUG
-
NPC-12G Gel 0.2%
Period 1
- DRUG
-
Rapamune® 2 mg tablet
Period 2
Sponsors & Collaborators
-
Nobelpharma
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-05-31
- Primary Completion
- 2019-06-17
- Completion
- 2019-06-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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