A Study to Assess the Bioavailability and Adhesion of Selegiline TDS in Healthy Subjects
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Nevada
-
Las Vegas, Nevada, Vereinigte Staaten, 89121
- Novum Pharmaceutical Research Services
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Selegiline Transdermal Delivery System on right arm
|
Selegiline TDS 6 mg/24 hours
|
|
Aktiver Komparator: EMSAM® Transdermal Delivery System on left arm
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EMSAM® TDS 6 mg/24 hours
|
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Aktiver Komparator: EMSAM® Transdermal Delivery System on right arm
|
EMSAM® TDS 6 mg/24 hours
|
|
Experimental: Selegiline Transdermal Delivery System on left arm
|
Selegiline TDS 6 mg/24 hours
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Bioequivalence between test formulation of Selegiline TDS and EMSAM® TDS
Zeitfenster: 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.
|
84 hours following administration of Selegiline TDS and EMSAM® TDS
|
|
Assessment of patch adhesion
Zeitfenster: 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).
|
24 hours following administration of Selegiline TDS and EMSAM® TDS
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Safety and tolerability assessments
Zeitfenster: From study enrollment through all study periods, up to 67 days.
|
Evaluation of safety and tolerability of the Selegiline TDS and EMSAM® TDS.
Study staff will monitor adverse events and patch tolerability during this period.
|
From study enrollment through all study periods, up to 67 days.
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- P-25-0011
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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