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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Bioequivalence between test formulation of Selegiline TDS and EMSAM® TDS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
EMSAM® Transdermal Delivery System on left arm
EMSAM® Transdermal Delivery System on left arm
干预措施: EMSAM® TDS 6 mg/24 hours (Drug)
Selegiline Transdermal Delivery System on right arm
Selegiline Transdermal Delivery System on right arm
干预措施: Selegiline TDS 6 mg/24 hours (Drug)
Selegiline Transdermal Delivery System on left arm
Selegiline Transdermal Delivery System on left arm
干预措施: Selegiline TDS 6 mg/24 hours (Drug)
EMSAM® Transdermal Delivery System on right arm
EMSAM® Transdermal Delivery System on right arm
干预措施: EMSAM® TDS 6 mg/24 hours (Drug)
结局指标
主要结局
Bioequivalence between test formulation of Selegiline TDS and EMSAM® TDS
时间窗: 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
时间窗: 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).
次要结局
- Safety and tolerability assessments(From study enrollment through all study periods, up to 67 days.)