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
Corium Innovations, Inc.
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.
Description
This is a single-dose, single-center, open-label, randomized crossover study (2 treatments, 2 periods and 4 sequences) of a generic test formulation of Selegiline TDS 6 mg/24 hours with the comparator EMSAM® TDS 6 mg/24 hours, with at least 56 days washout period, recruiting around 92 healthy male and female subjects. For each study period, subjects will be admitted and confined in the clinical study site the night before the study day from at least 10 hours before dosing and they will be discharged once all PK, safety and tolerability are completed at 72 hours after dosing. Subjects will be…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 d…
Interventions
- DrugSelegiline TDS 6 mg/24 hours
Selegiline TDS 6 mg/24 hours
- DrugEMSAM® TDS 6 mg/24 hours
EMSAM® TDS 6 mg/24 hours
Location
- Novum Pharmaceutical Research ServicesLas Vegas, Nevada