Determine the Bioavailability of Selegiline TDS 6mg/24 Hours vs EMSAM in Healthy Subjects

NCT06607744 | Completed DMC FDA Drug

• 1 other identifier: SE101
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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

MDD

Keywords

Selegiline TDS; Bioavailability; Pharmacokinetic

Outcome Measures

Primary Outcomes (8)

• Plasma Pharmacokinetic-AUC 0-t

  The area under the plasma concentration-time curve from time 0 to the last measurable concentration is calculated by the linear/log trapezoidal method where the liner trapezoidal method is applied up to Tmax and the log trapezoidal method is used after Tmax.

  22 days

• Plasma Pharmacokinetic-AUC 0-∞

  The area under the plasma concentration-time curve from time 0 to infinity is calculated as the sum of AUC0-t and Ct/Kel, where Ct is the last measurable concentration.

  22 days

• Plasma Pharmacokinetic-Cmax

  The maximum plasma concentration following drug administration

  22 days

• Plasma Pharmacokinetic-Tmax

  The time to achieve maximum plasma concentration is determined directly from the individual plasma concentration-time curves

  22 days

• Plasma Pharmacokinetic-T1/2

  The terminal elimination half-life is calculated as 0.693/Kel

  22 days

• Plasma Pharmacokinetic-Tlag

  The time prior to achieving the first measurable plasma concentration (if applicable)

  22 days

• Plasma Pharmacokinetic-MTR

  The mean residence time

  22 days

• Plasma Pharmacokinetic-λz (Lambda z)

  Individual estimate of the terminal elimination rate constant, calculated using log-linear regression of the terminal portions of the plasma concentration-versus-time curves

  22 days

Secondary Outcomes (1)

• Safety-Topic Skin Irritation

  22 days

Study Arms (2)

Group1: Selegiline TDS of test formulation (6mg/24 hours)

Group1: 1 x Selegiline TDS 6 mg/24 hours manufactured by Corium Innovations, Inc., worn over 24 hours on cleaned upper left or right arm approximately from 8 AM following the randomisation schedule.

Drug: Pharmacokinetic profiles of Selegiline TDS and EMSAM

Group2: EMSAM TDS (6 mg/24 hours)

1 x EMSAM® TDS 6 mg/24 hours manufactured by Somerset Pharmaceuticals, Inc., worn over 24 hours on cleaned upper left or right arm approximately from 8 AM following the randomisation schedule.

Drug: Pharmacokinetic profiles of Selegiline TDS and EMSAM

Interventions

Pharmacokinetic profiles of Selegiline TDS and EMSAM DRUG

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.

Also known as: Systemic and local tolerability

Group1: Selegiline TDS of test formulation (6mg/24 hours); Group2: EMSAM TDS (6 mg/24 hours)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Biological sex
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Local subjects participate in the Hospital Ampang, Malaysia

You may qualify if:

• Subject age between 18 to 55 years old with adequate contraception but without taking oral contraceptives.
• Subject body weight ≤ 120 kg, with a BMI within 18-30 kg/m².
• Subject is able to complete the clinical study including the follow-up.
• Subject is capable of providing written informed consent.
• Subjects are able and willing to follow the requirements of the study and wearing patches.

You may not qualify if:

• Breastfeeding female.
• Pregnancy test positive female.
• At rest systolic blood pressure outside 90-140 mmHg or diastolic blood pressure outside 50- 90 mmHg or orthostatic hypotension.
• At rest sinus bradycardia defined as symptomatic heart rate \< 50 bpm, or asymptomatic heart rate \< 45 bpm; and sinus tachycardia defined as heart rate \> 100 bpm.
• Clinically significant ECG abnormalities (PQ interval \> 0.2 s, Duration of the QRS complex \> 0.1 s, AV block).
• QTc \> 450 ms for male and \> 460 ms for female.
• A history of allergies, or any significant adverse reactions, to any medications, unless the clinician considers that they are not clinically significant.
• Clinically significant medical history of eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, genitourinary, neurological, haematopoietic, lymphatic, endocrine, metabolic, dermatological, musculoskeletal, psychological, family history or surgical history.
• Family history of sudden cardiac death or pheochromocytoma.
• Clinically significant physical examination finding or psychiatric unstable conditions or psychiatric illness requiring treatment.
• Clinically significant laboratory abnormalities.
• Haemoglobin \< 12.0 g/dL for male and \< 11.0 g/dL for female at screening.
• Total bilirubin \> 1.25 x upper limit of normal, ALT/AST \> 1.5 x upper limit of normal.
• Hepatitis B, Hepatitis C or HIV positive.
• Urine DOA test positive.

Sponsors & Collaborators

• Corium Innovations, Inc.: lead

Study Sites (2)

Sarawak General Hospital

Samoran, Sarawak, 94300, Malaysia

Location

Hospital Ampang

Ampang, Selangor, 68000, Malaysia

Location

Related Links

• FDA Approved Drugs

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Interventions

Selegiline

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 22 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: February 10, 2025
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: February 25, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)