JPRN-jRCT2080222090未知1 期
A phase 1 study of E2022 tape formulation for application sites and intervals
试验速览
- 阶段
- 1 期
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 65age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •1. Male non-smokers (not smoking at least 4 weeks before Period 1) aged 65 years or older at informed consent,
- •2. BMI at screening is 18.5 kg/m2 or above - below 28.0 kg/m2,
- •3. Written informed consent,
- •4. Given full explanation of this study and is willing to and able to comply with the protocol requirements
排除标准
- •1. Have a current or past history of disorder reequiring medical treatment within 8 weeks before the first application or infection within 4 weeks before the first application,
- •2. Have a disorder within 4 weeks before the first application which affects the evaluation of study drug such as psychiatric, gastrointestinal, hepatic, renal, respiratory, endocrinological, hematological, neurological or cardiovascular system, or congenital metabolic abnormality,
- •3. Have a history of gastrointestinal surgery (e.g., liver, kidney, digestive tract) which affects the pharmacokinetics of study drug,
- •4. Have a history of treatment-requiring drug or food allergy or seasonal allergy at screening,
- •5. Had caffeine-containing food or drink or alcohol within 72 hours before study drug application in Period 1,
- •6. Had nutritional suppliments, herbal preparations (including oriental medicines) or others (e.g., grapefruit-containing food or beverage which may affect drug metabolizing enzymes and transporters, within 1 weeks before Period 1,
- •7. Have used liquid products (including cosmetics) on study application sites (back, upper limbs, chest), patch, tape or bandage, within 4 weeks before Period 1,
- •8. Present or past clinical signs of skin hypersensitivity to topical product or atopic dermatitis,
- •9. Excessively hairy or have shaved at application sites (back, upper limbs, chest) within 4 weeks before Period 1,
- •10.Eczema, dermatitis, abnormal pigmentation, injury, or scar at application sites which may affect the evaluation of skin symptoms
研究者
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