Determine the Bioavailability of Selegiline TDS 6mg/24 Hours vs EMSAM in Healthy Subjects
NCT06607744 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12
Last updated 2026-02-25
Summary
The goal of this clinical study is to obtain the bioavailability of the test patch of a generic formulation of Selegiline TDS 6mg/24 hours by Corium Innovations against the comparator (EMSAM), and the systemic and local safety and tolerability will be also observed and evaluated.
Conditions
Interventions
- DRUG
-
Pharmacokinetic profiles of Selegiline TDS and EMSAM
Selegiline concentrations will be measured in blood plasma using a validated liquid chromatography tandem mass spectrometry method from Selegiline TDS (test formulation 6mg/24 hours) and EMSAM (6mg/24 hours). The analytical laboratory will be blinded as to samples which are the test and reference products.
Sponsors & Collaborators
-
Corium Innovations, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-02-10
- Primary Completion
- 2025-03-25
- Completion
- 2025-03-25
- FDA Drug
- Yes
Countries
- Malaysia
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