- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07571824
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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
-
-
Nevada
-
Las Vegas, Nevada, 미국, 89121
- Novum Pharmaceutical Research Services
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Selegiline Transdermal Delivery System on right arm
|
Selegiline TDS 6 mg/24 hours
|
|
활성 비교기: EMSAM® Transdermal Delivery System on left arm
|
EMSAM® TDS 6 mg/24 hours
|
|
활성 비교기: EMSAM® Transdermal Delivery System on right arm
|
EMSAM® TDS 6 mg/24 hours
|
|
실험적: Selegiline Transdermal Delivery System on left arm
|
Selegiline TDS 6 mg/24 hours
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bioequivalence between test formulation of Selegiline TDS and EMSAM® TDS
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Safety and tolerability assessments
기간: 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.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- P-25-0011
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .