Bioequivalence and Adhesion Assessment Between Two Rivastigmine Transdermal Patch Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This study evaluates the bioequivalence and adhesion performance of a test rivastigmine transdermal patch compared with the reference product, Exelon® Patch 10 (9.5 mg/24 h), in healthy adult volunteers of both sexes under fasting conditions. The pharmacokinetic profiles will be compared to assess whether the test product demonstrates equivalent rate and extent of absorption to the reference formulation. Patch adhesion will also be evaluated throughout the dosing interval to determine whether the test product shows high adhesion (>90%) or non-inferior adhesion compared with the reference product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 18.5 and 30.0 kg/m².
- •Non-smokers or former smokers who stopped smoking at least 1 year prior to screening.
- •Clinically healthy based on medical history, physical examination, vital signs, ECG, and clinical laboratory tests.
- •Negative screening for HIV, hepatitis B, and hepatitis C.
- •Female participants must not be pregnant or breastfeeding and must have a negative pregnancy test.
- •No hair, wounds, or dermatological conditions at the intended patch application site (upper arm).
- •Able to understand the study procedures and provide written informed consent
排除标准
- •History or presence of clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, metabolic, pulmonary, or dermatological diseases.
- •Known hypersensitivity to rivastigmine, carbamate derivatives, or any component of the study formulation.
- •Abnormal clinical laboratory results, vital signs, or ECG considered clinically significant by the investigator.
- •Positive test results for drugs of abuse, alcohol misuse, HIV, hepatitis B, or hepatitis C.
- •Use of prescription or non-prescription medications that could interfere with the study drug within a defined period prior to dosing, as determined by the investigator.
- •Participation in another clinical trial or exposure to an investigational drug within the previous 6 months.
- •Blood donation or significant blood loss within 3 months prior to the study.
- •Consumption of grapefruit-containing products, alcohol, or substances that could interfere with drug metabolism prior to dosing.
- •Use of medications known to significantly affect hepatic metabolism.
- •Dermatological conditions or skin alterations that could interfere with patch adhesion or drug absorption.
- •Positive or suspected infection with SARS-CoV-2 prior to study periods.
- •Any condition that, in the investigator's judgment, could interfere with study participation or the interpretation of study results.
研究组 & 干预措施
Test
Single application of the test rivastigmine transdermal patch (9.5 mg/24 h) for a 24-hour wear period.
干预措施: Rivastigmine TDS 9,5 mg/24 h (Drug)
Comparator
Single application of the reference rivastigmine transdermal patch (Exelon® Patch 10, 9.5 mg/24 h) for a 24-hour wear period.
干预措施: Exelon® 9.5 mg/24 h (Drug)
结局指标
主要结局
Cmax
时间窗: Up to 48 hours after patch application
Maximum observed plasma concentration of rivastigmine following application of the transdermal patch.
AUC0-t
时间窗: Up to 48 hours after patch application
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration of rivastigmine.
AUC0-12
时间窗: 0 to 12 hours after patch application
Area under the plasma concentration-time curve of rivastigmine from time zero to 12 hours after patch application.
AUC12-t
时间窗: 12 to 48 hours after patch application
Area under the plasma concentration-time curve of rivastigmine from 12 hours to the last quantifiable concentration.
Patch Adhesion
时间窗: 24 hours after patch application
Percentage of the transdermal patch surface remaining adhered to the skin at the end of the 24-hour dosing interval.
次要结局
未报告次要终点