Healthy Adult ParticipantsPhase 1NCT07571824
A Study to Assess the Bioavailability and Adhesion of Selegiline TDS in Healthy Subjects
A Phase 1 study testing Selegiline TDS 6 mg/24 hours and EMSAM® TDS 6 mg/24 hours in people with Healthy Adult Participants, run by Corium Innovations, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Selegiline TDS 6 mg/24 hours and EMSAM® TDS 6 mg/24 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2026to 16 Jun 2026
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the subject or integrity of the study.
- Presence of any skin condition such as scratches, cuts, rash, scars, abrasions, excessive hair, tattoos or similar embodiments, moles, recently shaved skin, uneven skin texture, sunburned skin, or excessively oily skin at the application areas that, in the opinion of the Investigator, may affect the application or adhesion of the study patch or the systemic absorption of selegiline from the patch.
- History or presence of any current dermatological condition such as atopy, psoriasis, eczema, chronic or atopic dermatitis, vitiligo, or urticaria which, in the opinion of the Investigator, would compromise the safety of the subject or the integrity of the study.
- Personal (or immediate family history, as deemed relevant by the Investigator) of psychiatric disorders such as bipolar disorder, mania, hypomania, suicidal thoughts or behaviors occurring within 2 years before initial patch application that required the subject, or immediate family member (if applicable), to be hospitalized or undergo treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novum Pharmaceutical Research Services
Las Vegas, Nevada, 89121
About this study
Official title: 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
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.
Read the detailed 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 required to return for subsequent PK, safety and tolerability at 84-hours post-dosing. The clinic will follow up by telephone 7 ± 3 days after subject completion of the study.
Trained study staff will also examine the patch application sites at scheduled time points and will score any skin reactions using standardized assessment scales. In addition, photographs of the patch application site will be taken to document adhesion status while the patch is being worn.
PK blood samples will be collected before dosing and at 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 25, 27, 28, 32, 36, 40, 44, 48, 60, 72 and 84 hours after dosing.
Furthermore, the overall safety of the test product will be compared with that of the comparator product by monitoring and recording any adverse events, side effects, or discomfort experienced by subjects during the study.
- Conditions
- Healthy Adult Participants
- Being tested
- Selegiline TDS 6 mg/24 hours, EMSAM® TDS 6 mg/24 hours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selegiline TDS 6 mg/24 hoursDrug
Selegiline TDS 6 mg/24 hours
EMSAM® TDS 6 mg/24 hoursDrug
EMSAM® TDS 6 mg/24 hours
| Study group | Role | What they receive |
|---|---|---|
| Selegiline Transdermal Delivery System on right arm | Experimental | Selegiline Transdermal Delivery System on right arm Receives: Drug: Selegiline TDS 6 mg/24 hours |
| EMSAM® Transdermal Delivery System on left arm | Active comparator | EMSAM® Transdermal Delivery System on left arm Receives: Drug: EMSAM® TDS 6 mg/24 hours |
| EMSAM® Transdermal Delivery System on right arm | Active comparator | EMSAM® Transdermal Delivery System on right arm Receives: Drug: EMSAM® TDS 6 mg/24 hours |
| Selegiline Transdermal Delivery System on left arm | Experimental | Selegiline Transdermal Delivery System on left arm Receives: Drug: Selegiline TDS 6 mg/24 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence between test formulation of Selegiline TDS and EMSAM® TDS
Bioequivalence between the test formulation of the Corium TDS, Selegiline Transdermal System, 6 mg/24 hours and the comparator, EMSAM®, 6 mg/24 hours will be assessed from pharmacokinetic sampling up to 84 hours following patch administration.
Measured: 84 hours following administration of Selegiline TDS and EMSAM® TDS
Assessment of patch adhesion
The primary endpoint of adhesion will be the Mean Adhesion Score (MAS) during the 24-hour application period. For the calculation of MAS, the highest adhesion score (representing the greatest degree of detachment) assessed at any time point will be used for subsequent time points until a higher score is assessed (Highest Observation Carried Forward [HOCF]). MAS for a specific subject and patch type will be derived from individual adhesion scores at each assessment time point averaged across all the equally spaced time points (except the baseline or time 0).
Measured: 24 hours following administration of Selegiline TDS and EMSAM® TDS
Secondary outcomes (1)
Safety and tolerability assessments
Evaluation of safety and tolerability of the Selegiline TDS and EMSAM® TDS. Study staff will monitor adverse events and patch tolerability during this period.
Measured: From study enrollment through all study periods, up to 67 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start23 Mar 2026
- Primary completion16 Jun 2026
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corium Innovations, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571824
- Sponsor's protocol ID
- P-25-0011
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07571824
- Acronym / sponsor ID
- P-25-0011
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Corium Innovations, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 6 May 2026 (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 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.
Detailed 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 required to return for subsequent PK, safety and tolerability at 84-hours post-dosing. The clinic will follow up by telephone 7 ± 3 days after subject completion of the study.
Trained study staff will also examine the patch application sites at scheduled time points and will score any skin reactions using standardized assessment scales. In addition, photographs of the patch application site will be taken to document adhesion status while the patch is being worn.
PK blood samples will be collected before dosing and at 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 25, 27, 28, 32, 36, 40, 44, 48, 60, 72 and 84 hours after dosing.
Furthermore, the overall safety of the test product will be compared with that of the comparator product by monitoring and recording any adverse events, side effects, or discomfort experienced by subjects during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Selegiline Transdermal Delivery System on right arm | Experimental | Drug: Selegiline TDS 6 mg/24 hoursSelegiline Transdermal Delivery System on right arm |
| EMSAM® Transdermal Delivery System on left arm | Active comparator | Drug: EMSAM® TDS 6 mg/24 hoursEMSAM® Transdermal Delivery System on left arm |
| EMSAM® Transdermal Delivery System on right arm | Active comparator | Drug: EMSAM® TDS 6 mg/24 hoursEMSAM® Transdermal Delivery System on right arm |
| Selegiline Transdermal Delivery System on left arm | Experimental | Drug: Selegiline TDS 6 mg/24 hoursSelegiline Transdermal Delivery System on left arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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 drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the subject or integrity of the study.
- Presence of any skin condition such as scratches, cuts, rash, scars, abrasions, excessive hair, tattoos or similar embodiments, moles, recently shaved skin, uneven skin texture, sunburned skin, or excessively oily skin at the application areas that, in the opinion of the Investigator, may affect the application or adhesion of the study patch or the systemic absorption of selegiline from the patch.
- History or presence of any current dermatological condition such as atopy, psoriasis, eczema, chronic or atopic dermatitis, vitiligo, or urticaria which, in the opinion of the Investigator, would compromise the safety of the subject or the integrity of the study.
- Personal (or immediate family history, as deemed relevant by the Investigator) of psychiatric disorders such as bipolar disorder, mania, hypomania, suicidal thoughts or behaviors occurring within 2 years before initial patch application that required the subject, or immediate family member (if applicable), to be hospitalized or undergo treatment.
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 |
|---|---|---|
| Selegiline TDS 6 mg/24 hoursSelegiline TDS 6 mg/24 hours | Drug | Selegiline Transdermal Delivery System on left arm, Selegiline Transdermal Delivery System on right arm |
| EMSAM® TDS 6 mg/24 hoursEMSAM® TDS 6 mg/24 hours | Drug | EMSAM® Transdermal Delivery System on left arm, EMSAM® Transdermal Delivery System on right arm |
Primary outcome
Bioequivalence between test formulation of Selegiline TDS and EMSAM® TDS
Time frame: 84 hours following administration of Selegiline TDS and EMSAM® TDS
Bioequivalence between the test formulation of the Corium TDS, Selegiline Transdermal System, 6 mg/24 hours and the comparator, EMSAM®, 6 mg/24 hours will be assessed from pharmacokinetic sampling up to 84 hours following patch administration.
Assessment of patch adhesion
Time frame: 24 hours following administration of Selegiline TDS and EMSAM® TDS
The primary endpoint of adhesion will be the Mean Adhesion Score (MAS) during the 24-hour application period. For the calculation of MAS, the highest adhesion score (representing the greatest degree of detachment) assessed at any time point will be used for subsequent time points until a higher score is assessed (Highest Observation Carried Forward [HOCF]). MAS for a specific subject and patch type will be derived from individual adhesion scores at each assessment time point averaged across all the equally spaced time points (except the baseline or time 0).
1 secondary outcome
Safety and tolerability assessments
Time frame: From study enrollment through all study periods, up to 67 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 1 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Selegiline TDS 6 mg/24 hours and EMSAM® TDS 6 mg/24 hours in people with Healthy Adult Participants, run by Corium Innovations, Inc. at 1 site in United States.
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 4 inclusion and 4 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bioequivalence between test formulation of Selegiline TDS and EMSAM® TDS (time frame: 84 hours following administration of Selegiline TDS and EMSAM® TDS). The study lists 2 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 1 Jul 2026.