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

NCT07571824 | Recruiting Phase 1 FDA Drug

• 1 other identifier: P-25-0011
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Bioequivalence between test formulation of Selegiline TDS and EMSAM® TDS

  Bioequivalence between the test formulation of the Corium TDS, Selegiline Transdermal System, 6 mg/24 hours and the comparator, EMSAM®, 6 mg/24 hours will be assessed from pharmacokinetic sampling up to 84 hours following patch administration.

  84 hours following administration of Selegiline TDS and EMSAM® TDS

• Assessment of patch adhesion

  The primary endpoint of adhesion will be the Mean Adhesion Score (MAS) during the 24-hour application period. For the calculation of MAS, the highest adhesion score (representing the greatest degree of detachment) assessed at any time point will be used for subsequent time points until a higher score is assessed (Highest Observation Carried Forward \[HOCF\]). MAS for a specific subject and patch type will be derived from individual adhesion scores at each assessment time point averaged across all the equally spaced time points (except the baseline or time 0).

  24 hours following administration of Selegiline TDS and EMSAM® TDS

Secondary Outcomes (1)

• Safety and tolerability assessments

  From study enrollment through all study periods, up to 67 days.

Study Arms (4)

Selegiline Transdermal Delivery System on right arm

EXPERIMENTAL

Selegiline Transdermal Delivery System on right arm

Drug: Selegiline TDS 6 mg/24 hours

EMSAM® Transdermal Delivery System on left arm

ACTIVE COMPARATOR

EMSAM® Transdermal Delivery System on left arm

Drug: EMSAM® TDS 6 mg/24 hours

EMSAM® Transdermal Delivery System on right arm

ACTIVE COMPARATOR

EMSAM® Transdermal Delivery System on right arm

Drug: EMSAM® TDS 6 mg/24 hours

Selegiline Transdermal Delivery System on left arm

EXPERIMENTAL

Selegiline Transdermal Delivery System on left arm

Drug: Selegiline TDS 6 mg/24 hours

Interventions

EMSAM® TDS 6 mg/24 hours DRUG

EMSAM® TDS 6 mg/24 hours

EMSAM® Transdermal Delivery System on left arm; EMSAM® Transdermal Delivery System on right arm

Selegiline TDS 6 mg/24 hours DRUG

Selegiline TDS 6 mg/24 hours

Selegiline Transdermal Delivery System on left arm; Selegiline Transdermal Delivery System on right arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Corium Innovations, Inc.: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Las Vegas, Nevada, 89121, United States

RECRUITING

Central Study Contacts

Ann Vollmer

CONTACT

(616) 656-4563; clinicaltrials@coriumintl.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: May 6, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): June 29, 2026
• Study Completion (Estimated): July 29, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)