A Study to Assess the Bioavailability and Adhesion of Selegiline TDS in Healthy Subjects
NCT07571824 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92
Last updated 2026-05-28
Summary
The purpose of this research study is to compare the bioavailability and adhesion of a generic Selegiline transdermal system (TDS) against the marketed comparator (EMSAM®) in healthy volunteers. Systemic and local safety and tolerability will be also observed and evaluated.
Conditions
- Healthy Adult Participants
Interventions
- DRUG
-
Selegiline TDS 6 mg/24 hours
Selegiline TDS 6 mg/24 hours
- DRUG
-
EMSAM® TDS 6 mg/24 hours
EMSAM® TDS 6 mg/24 hours
Sponsors & Collaborators
-
Corium Innovations, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-23
- Primary Completion
- 2026-06-29
- Completion
- 2026-07-29
- FDA Drug
- Yes
Countries
- United States
Study Locations
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