Actively Recruiting
A Study to Assess the Bioavailability and Adhesion of Selegiline TDS in Healthy Subjects
Led by Corium Innovations, Inc. · Updated on 2026-05-06
92
Participants Needed
1
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Assess the Bioavailability and Adhesion of Selegiline TDS in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female non-smoking subject
- Body weight up to 120 kg and BMI between 18.5 and 29.9 kg/m2 inclusive
- Good health with no clinically significant abnormalities as determined by health assessments at screening
- Able and willing to follow protocol restrictions and required study procedures
You will not qualify if you...
- Allergy, hypersensitivity, or intolerance to selegiline, MAOIs, EMSAM4, or any patch components
- Skin conditions at application sites such as scratches, cuts, rash, scars, excessive hair, tattoos, recently shaved skin, uneven texture, sunburn, or excessively oily skin that may affect patch adhesion or absorption
- Current or history of dermatological conditions including atopy, psoriasis, eczema, chronic or atopic dermatitis, vitiligo, or urticaria
- Personal or relevant immediate family history of psychiatric disorders like bipolar disorder, mania, hypomania, or suicidal thoughts/behaviors within 2 years before patch application requiring hospitalization or treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Novum Pharmaceutical Research Services
Las Vegas, Nevada, United States, 89121
Actively Recruiting
Research Team
A
Ann Vollmer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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