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

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
Corium Innovations, Inc.
Study ID
NCT07571824
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Healthy Adult Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Selegiline TDS 6 mg/24 hours — DRUG
    Selegiline TDS 6 mg/24 hours
  • EMSAM® TDS 6 mg/24 hours — DRUG
    EMSAM® TDS 6 mg/24 hours

Study Details

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 Dates

Start date
Mar 23, 2026
Status verified
May 2026
Primary completion
Jun 29, 2026
Completion
Jul 29, 2026

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Selegiline Transdermal Delivery System on right arm
    Selegiline Transdermal Delivery System on right arm
  • Active Comparator: EMSAM® Transdermal Delivery System on left arm
    EMSAM® Transdermal Delivery System on left arm
  • Active Comparator: EMSAM® Transdermal Delivery System on right arm
    EMSAM® Transdermal Delivery System on right arm
  • Experimental: Selegiline Transdermal Delivery System on left arm
    Selegiline Transdermal Delivery System on left arm

Primary Outcome Measure

Bioequivalence between test formulation of Selegiline TDS and EMSAM® TDS [ Time Frame: 84 hours following administration of Selegiline TDS and EMSAM® TDS ]

Locations (1)

FacilityCityStateZIPSite coordinators
Novum Pharmaceutical Research ServicesLas VegasNevada89121-

Find similar trials in Las Vegas, NV

By research site
Novum Pharmaceutical Research Services· Las Vegas, NV

Related Studies