MDDTDSNCT06607744
Determine the Bioavailability of Selegiline TDS 6mg/24 Hours vs EMSAM in Healthy Subjects
An observational study of MDD, run by Corium Innovations, Inc. at 2 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- MDD
- What is being tested?
- Pharmacokinetic profiles of Selegiline TDS and EMSAM
- How many people
- 12 participants
- Where
- 2 sitesMalaysia
- Study dates
- 10 Feb 2025to 25 Mar 2025
- How long will I take part?
- 22 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Local subjects participate in the Hospital Ampang, Malaysia
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
- Breath alcohol test positive.
- Any smoker with tobacco or electronic tobacco products.
- 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).
- 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.
- 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.
- Clinically significant illness or injury or hospitalisation for any reason within 28 days before consent taking.
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
Hospital Ampang
Ampang, Selangor, 68000
Sarawak General Hospital
Samoran, Sarawak, 94300
About this study
Official title: 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
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.
Read the detailed description
This is a pilot, single-dose, single-centre, open-label, randomised, 2-way crossover study (2 treatments, 2 periods and 2 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 14 days washout period, recruiting around 12 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 36 hours after dosing. Subjects will be required to return for subsequent PK, safety and tolerability at 48-, 72- and 96-hours post-dosing. The clinic will follow up by telephone 7 ± 3 days after completion of the study.
Pharmacokinetic Blood Sampling:
PK blood samples will be collected before dosing and at 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 30, 36, 48, 72, 96 hours after dosing.
Pharmacokinetics:
PK parameters include AUC0-t, AUC0-∞, Cmax, tmax, t½, tlag (if applicable), λz, and Mean residence time (MRT) will be evaluated for Selegiline.
Safety:
Safety will be assessed on all subjects who participate in the study from the beginning to the end. Adverse events (AEs), abnormal vital signs, abnormal ECG results, abnormal physical examination findings and abnormal clinical laboratory test results will be reviewed on a subject-to-subject basis.
- Conditions
- MDD
- Being tested
- Pharmacokinetic profiles of Selegiline TDS and EMSAM
- Keywords
- Selegiline TDS, Bioavailability, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic profiles of Selegiline TDS and EMSAMDrug
Also called Systemic and local tolerability
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Pharmacokinetic profiles of Selegiline TDS and EMSAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 22 days
Plasma Pharmacokinetic-Cmax
The maximum plasma concentration following drug administration
Measured: 22 days
Plasma Pharmacokinetic-Tmax
The time to achieve maximum plasma concentration is determined directly from the individual plasma concentration-time curves
Measured: 22 days
Plasma Pharmacokinetic-T1/2
The terminal elimination half-life is calculated as 0.693/Kel
Measured: 22 days
Plasma Pharmacokinetic-Tlag
The time prior to achieving the first measurable plasma concentration (if applicable)
Measured: 22 days
Plasma Pharmacokinetic-MTR
The mean residence time
Measured: 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
Measured: 22 days
Secondary outcomes (1)
Safety-Topic Skin Irritation
Each application site will receive a separate dermal response score and other effect score. Dermal response scores require that at least 25% or more of the patch area demonstrate an observable response. The percentage of the patch area demonstrating an observable response will also be recorded. "Strong" reaction to the transdermal patch is defined as a dermal response score of 3-7 or any dermal response score combined with other effect score of 4 or greater.
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start10 Feb 2025
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
- Target duration
- 22 Days
Sponsor and investigators
- Lead sponsor
- Corium Innovations, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607744
- Sponsor's protocol ID
- SE101
- Acronym
- TDS
- Status last verified
- Feb 2025
- First submitted
- 18 Sep 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06607744
- Acronym / sponsor ID
- TDS / SE101
- Conditions
- MDD
- Keywords
- Selegiline TDS, Bioavailability, Pharmacokinetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Corium Innovations, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a pilot, single-dose, single-centre, open-label, randomised, 2-way crossover study (2 treatments, 2 periods and 2 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 14 days washout period, recruiting around 12 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 36 hours after dosing. Subjects will be required to return for subsequent PK, safety and tolerability at 48-, 72- and 96-hours post-dosing. The clinic will follow up by telephone 7 ± 3 days after completion of the study.
Pharmacokinetic Blood Sampling:
PK blood samples will be collected before dosing and at 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 30, 36, 48, 72, 96 hours after dosing.
Pharmacokinetics:
PK parameters include AUC0-t, AUC0-∞, Cmax, tmax, t½, tlag (if applicable), λz, and Mean residence time (MRT) will be evaluated for Selegiline.
Safety:
Safety will be assessed on all subjects who participate in the study from the beginning to the end. Adverse events (AEs), abnormal vital signs, abnormal ECG results, abnormal physical examination findings and abnormal clinical laboratory test results will be reviewed on a subject-to-subject basis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 22 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1: Selegiline TDS of test formulation (6mg/24 hours) | – | Drug: Pharmacokinetic profiles of Selegiline TDS and EMSAMGroup1: 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. |
| Group2: EMSAM TDS (6 mg/24 hours) | – | Drug: Pharmacokinetic profiles of Selegiline TDS and EMSAM1 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Local subjects participate in the Hospital Ampang, Malaysia
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacokinetic profiles of Selegiline TDS and EMSAMAlso: Systemic and local tolerabilitySelegiline 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. | Drug | Group1: Selegiline TDS of test formulation (6mg/24 hours), Group2: EMSAM TDS (6 mg/24 hours) |
Primary outcome
Plasma Pharmacokinetic-AUC 0-t
Time frame: 22 days
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.
Plasma Pharmacokinetic-AUC 0-∞
Time frame: 22 days
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.
Plasma Pharmacokinetic-Cmax
Time frame: 22 days
The maximum plasma concentration following drug administration
Plasma Pharmacokinetic-Tmax
Time frame: 22 days
The time to achieve maximum plasma concentration is determined directly from the individual plasma concentration-time curves
Plasma Pharmacokinetic-T1/2
Time frame: 22 days
The terminal elimination half-life is calculated as 0.693/Kel
Plasma Pharmacokinetic-Tlag
Time frame: 22 days
The time prior to achieving the first measurable plasma concentration (if applicable)
Plasma Pharmacokinetic-MTR
Time frame: 22 days
The mean residence time
Plasma Pharmacokinetic-λz (Lambda z)
Time frame: 22 days
Individual estimate of the terminal elimination rate constant, calculated using log-linear regression of the terminal portions of the plasma concentration-versus-time curves
1 secondary outcome
Safety-Topic Skin Irritation
Time frame: 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- FDA Approved DrugsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MDD, run by Corium Innovations, Inc. at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Pharmacokinetic-AUC 0-t (time frame: 22 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.