An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Sandoz
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Patch Adhesion
研究概览
简要总结
The objective of this study is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.
详细描述
The objective of this clinical trial is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.
The following evaluations will be assessed as "yes" or "no":
- Cold flow (dark ring formed around the patch)
- Patch movement/displacement
- Patch wrinkling
- Residue formation (at patch application on the release liner and at patch removal on the skin) Safety and tolerability of a single dose application of a patch containing 18 mg rotigotine (Test) against a patch containing 18 mg rotigotine (Reference) will be evaluated in terms of vital signs and AEs.
AEs and clinical tolerability will be monitored at all clinical trial visits. The safety evaluation will be based upon the review of the individual values (potentially clinically important abnormalities) and descriptive statistics (summary tables, graphics).
As additional safety parameters for the clinical trial physical examination findings, clinical laboratory parameters, and 12-lead ECGs will be assessed at the screening and follow-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with idiopathic Parkinson's Disease assessed as eligible for receiving 18 mg/IRR 8 mg/24 h rotigotine via the test and the reference product each on subsequent days in order to reach the dose of active substance at the individual routine medical care. Patients should be on a stable rotigotine dose of at least 8 mg/24 h for at least 1 week before screening.
排除标准
- •Current participation in another clinical trial, participation in another clinical study (i.e. last protocol specified visit) involving another IMP within at least 28 days prior to first application or previous participation in this clinical Trial
- •History or presence of clinically significant dermatologic diseases or conditions, such as atopy, neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell carcinoma.
- •History or presence of any dermatological condition or skin sensitivity that could affect IMP Absorption
- •History of clinically relevant (severe) hypersensitivity to the active pharmaceutical ingredient or substances of the same class or one of the excipients, clinically relevant allergy.
研究组 & 干预措施
Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference)
For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h
干预措施: Rotigotine TTS (Test) (Drug)
Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference)
For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h
干预措施: Neupro (Reference) (Drug)
Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test)
For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h
干预措施: Rotigotine TTS (Test) (Drug)
Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test)
For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h
干预措施: Neupro (Reference) (Drug)
结局指标
主要结局
Patch Adhesion
时间窗: 24 hours in each Treatment Period
Patch Adhesion will be measured as the percentage of area that remained adhered after 24 hours of patch application.
次要结局
- Number of patients with cold flow(24 hours in each Treatment Period)
- Number of patients with patch movement/displacement(24 hours in each Treatment Period)
- Number of patients with patch wrinkling(24 hours in each Treatment Period)
- Number of patients with patch residue formation(24 hours in each Treatment Period)