Open Label Trial to Evaluate the Adhesion of TK-254RX in Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Characterization of adhesion 5 minutes prior to removal by the adhesion assessment by site staff with EFTS marked by site staff
研究概览
简要总结
This study is a multi center, multiple dose, open label trial to evaluate the adhesion of TK-254RX in healthy volunteers. The primary purpose of this study is to evaluate the adhesion of TK-254RX. Secondary purpose is to show TK-254RX is safe and to explore and compare adhesion assessment methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 18 to 64 years
- •good state of health
- •non-smoker or ex-smoker for at least 3 months
- •written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial
排除标准
- •The following must not apply:
- •any injury of body which may induce the restriction of body movement
- •excessively hairy skin at application site
- •current skin disorder or shaving hair at application site
- •history of excessive sweating/hyperhidrosis inclusive of application site
- •participation in a clinical study within 30 days before inclusion in the study or concomitantly
- •drug or alcohol abuse in the opinion of the investigator
- •pregnant and lactating women
- •women of child-bearing potential who do not agree to apply highly effective contraceptive methods
- •known hypersensitivity to active ingredient, its racemate or one of the excipients of the TK-254RX
- •existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- •existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- •known liver or kidney insufficiency
- •existing gastrointestinal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- •history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- •systolic blood pressure < 90 or > 139 mmHg
- •diastolic blood pressure < 60 or > 89 mmHg
- •pulse rate < 50 bpm or > 90 bpm
- •subjects who use any impermissible medication
研究组 & 干预措施
TK-254RX applied to Lower Arm, Lower thigh or Ankle
For Group1, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects.
Day1: Lower Arm, Day2: Lower thigh, Day3: Ankle
干预措施: TK-254RX (Drug)
TK-254RX applied to Upper Arm, Upper thigh or Lower leg
For Group2, TK-254RX will be applied to left and right side (total of two TK-254RX per day) of the following predetermined application site by subjects.
Day1: Upper Arm, Day2: Upper thigh, Day3: Lower leg
干预措施: TK-254RX (Drug)
结局指标
主要结局
Characterization of adhesion 5 minutes prior to removal by the adhesion assessment by site staff with EFTS marked by site staff
时间窗: 5 minutes prior to removal,
Assessment/estimation by site staff with marked TK-254RX by site staff: A listing of individual values of percentage will be presented per time point and subject. Descriptive statistics (Number, arithmetic mean, standard deviation, median, minimum and maximum) will be presented per time point for adhesion marker assessment by site staff with marked TK-254RX by site staff (percentage values).
次要结局
- Characterization of adhesion by visual estimation of subjects(before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal)
- Characterization of adhesion by the adhesion assessment by site staff with EFTS marked by subjects(before bedtime (-1hour), after waking up (+1hour), 5minutes prior to removal)
- Comparison of the adhesion assessments between subjects and study staff(5minutes prior to removal)
- Characterization of local tolerability during treatment(within 5 minutes after removal of each patch)