A Study to Assess the Bioavailability and Adhesion of Selegiline TDS in Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy Adult Participants

In brief

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.

Key facts

Study ID

NCT07571824

Run by

Corium Innovations, Inc.

People needed

92

Starts

2026-03-23

Expected to finish

2026-06-16

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female non-smoking subject.
• A body weight ≤ 120 kg and a BMI of 18.5-29.9 kg/m², inclusive.
• Good health as determined by lack of clinically significant abnormalities in the health assessments performed at screening, as deemed by the Investigator (or designee).
• Able and willing to comply with protocol restrictions and required study procedures.

You may not qualify if…

• History of allergy, hypersensitivity or idiosyncrasy to selegiline or other monoamine oxidase inhibitors (MAOIs), EMSAM® or any of its components, including glues/adhesives, or history of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the subject or integrity of the study.
• Presence of any skin condition such as scratches, cuts, rash, scars, abrasions, excessive hair, tattoos or similar embodiments, moles, recently shaved skin, uneven skin texture, sunburned skin, or excessively oily skin at the application areas that, in the opinion of the Investigator, may affect the application or adhesion of the study patch or the systemic absorption of selegiline from the patch.
• History or presence of any current dermatological condition such as atopy, psoriasis, eczema, chronic or atopic dermatitis, vitiligo, or urticaria which, in the opinion of the Investigator, would compromise the safety of the subject or the integrity of the study.
• Personal (or immediate family history, as deemed relevant by the Investigator) of psychiatric disorders such as bipolar disorder, mania, hypomania, suicidal thoughts or behaviors occurring within 2 years before initial patch application that required the subject, or immediate family member (if applicable), to be hospitalized or undergo treatment.

Where it is running

• Novum Pharmaceutical Research Services — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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