Comparing the bioavailability of Selegiline patches to EMSAM in healthy individuals

The Comparative Pilot Bioavailability Study of a Generic Test Formulation of Selegiline TDS 6 mg/24 Hours Against the Comparator EMSAM® 6 mg/24 Hours in Healthy Adult Subjects

This study is testing a new generic Selegiline patch to see how well it works compared to the brand name EMSAM in healthy people.

Quick facts

• Study type: Observational
• Enrollment: 12 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Corium Innovations, Inc. (Industry-sponsored)
• Locations: 2 sites (Pandan Mewah, Ampang and 1 other locations)
• Trial ID: NCT06607744 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the bioavailability of a generic formulation of Selegiline transdermal system (TDS) 6 mg/24 hours compared to the branded EMSAM TDS 6 mg/24 hours. It is designed as a pilot, single-dose, open-label, randomized, 2-way crossover study involving approximately 12 healthy subjects. Participants will be monitored for pharmacokinetic parameters and safety over a period of 96 hours post-dosing, with blood samples collected at various intervals to assess drug absorption and tolerability. The study will also include a washout period of at least 14 days between treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 18 to 55 who meet specific health criteria and can provide informed consent.

Not a fit: Patients who are pregnant, breastfeeding, or have significant cardiovascular issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness and safety of a new generic Selegiline patch formulation for treating major depressive disorder.

How similar studies have performed: While this approach is relatively novel, previous studies on the pharmacokinetics of Selegiline have shown promising results.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Breastfeeding female.
2. Pregnancy test positive female.
3. At rest systolic blood pressure outside 90-140 mmHg or diastolic blood pressure outside 50- 90 mmHg or orthostatic hypotension.
4. 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.
5. Clinically significant ECG abnormalities (PQ interval \> 0.2 s, Duration of the QRS complex \> 0.1 s, AV block).
6. QTc \> 450 ms for male and \> 460 ms for female.
7. A history of allergies, or any significant adverse reactions, to any medications, unless the clinician considers that they are not clinically significant.
8. 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.
9. Family history of sudden cardiac death or pheochromocytoma.
10. Clinically significant physical examination finding or psychiatric unstable conditions or psychiatric illness requiring treatment.
11. Clinically significant laboratory abnormalities.
12. Haemoglobin \< 12.0 g/dL for male and \< 11.0 g/dL for female at screening.
13. Total bilirubin \> 1.25 x upper limit of normal, ALT/AST \> 1.5 x upper limit of normal.
14. Hepatitis B, Hepatitis C or HIV positive.
15. Urine DOA test positive.
16. Breath alcohol test positive.
17. Any smoker with tobacco or electronic tobacco products.
18. A history of drug or substance abuse, including alcohol (≥ 14 units per week) within 6 months before consent taking (1 unit of alcohol equals approximately ½ pint \[285 mL\] of beer, 1 glass \[125 mL\] of wine, or 1 shot \[25 mL\] of spirit).
19. Taking selective serotonin reuptake inhibitors (SSRI), serotonin and norepinephrine reuptake inhibitors (SNRI) or cough or cold medicine (e.g., dextromethorphan, pseudoephedrine) or using carbamazepine or oxcarbazepine, or using meperidine and analgesic agents such as tramadol, methadone, and propoxyphene, or using sympathomimetic agents.
20. Unable to refrain from taking any medications (including herbal remedies) within 7 days before dosing, with the exception of birth control medications and other medications deemed acceptable by the Investigator.
21. Clinically significant illness or injury or hospitalisation for any reason within 28 days before consent taking.

Where this trial is running

Pandan Mewah, Ampang and 1 other locations

• Hospital Ampang — Pandan Mewah, Ampang, Malaysia (Recruiting)
• Sarawak General Hospital — Samoran, Sarawak, Malaysia (Active_not_recruiting)

Study contacts

• Study coordinator: David Xu, Director of Clinical Department, MD, PhD

Conditions MDD; Selegiline TDS; Bioavailability; Pharmacokinetic