Bioavailability and adhesion comparison of selegiline transdermal patches in healthy adults
A Study to Compare the Bioequivalence and Adhesion Between a Test Selegiline Transdermal Delivery System (TDS) and Reference EMSAM® (Selegiline TDS) at the Same Strength (6 mg/24 Hours) for 24 Hours in Healthy Adult Subjects
This trial will test whether a generic selegiline patch delivers similar blood levels and sticks as well as the branded EMSAM patch in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Corium Innovations, Inc. Industry-sponsored |
| Locations | 1 site (Las Vegas, Nevada) |
| Trial ID | NCT07571824 on ClinicalTrials.gov |
What this trial studies
This is a single-dose, open-label, randomized 2‑period crossover study comparing a generic selegiline transdermal system (6 mg/24 h) with the marketed EMSAM® patch in about 92 healthy adult non-smokers. Each subject receives both patches in separate periods with at least a 56‑day washout, with confinement the night before dosing and intensive PK and safety monitoring through 84 hours after dosing. Frequent blood sampling over 84 hours will characterize systemic exposure and pharmacokinetic parameters, while trained staff will score and photograph patch adhesion and local skin reactions at scheduled time points. Adverse events and tolerability measures will be recorded to compare overall safety between the two products.
Who should consider this trial
Good fit: Healthy adult volunteers who are non-smokers, meet BMI/weight limits, have no significant medical issues, and have intact, unblemished skin at patch application sites are the intended participants.
Not a fit: People with known allergy or intolerance to selegiline/MAOIs, those with contraindicated skin conditions at application sites, or anyone seeking direct therapeutic benefit from the drug rather than volunteering for a healthy‑subject study are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the generic patch could provide patients with an alternative selegiline transdermal product with similar delivery and adhesion characteristics to the branded patch, potentially increasing access or lowering cost.
How similar studies have performed: Comparable single‑dose bioavailability and adhesion crossover studies of transdermal products, including branded patches, have been routinely performed and used successfully to support regulatory decisions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Las Vegas, Nevada
- Novum Pharmaceutical Research Services — Las Vegas, Nevada, United States (Recruiting)
Study contacts
- Study coordinator: Ann Vollmer
- Email: clinicaltrials@coriumintl.com
- Phone: (616) 656-4563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.