JPRN-jRCT2051220112已完成2 期
A Phase II Study to Evaluate the Pharmacokinetics and Safety of MR19A13A in Pediatric Patients.
obuyo Oya0 个研究点目标入组 12 人开始时间: 2022年10月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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
- >= 6month old 至 < 16age old（—）
- 性别
- All
入选标准
- •1) Japanese Patients aged from 6 months to 16 years, at the time of informed consent.
- •2) Patients with written consent from their legal representatives; If the patient is over 7 years, it is desirable to obtain the assent also from the patient as possible.
排除标准
- •1) Patients with the history of hypersensitivity or suspected hypersensitivity to any ingredients of the study drug.
- •2) Patients with acute angle-closure glaucoma.
- •3) Patients with myasthenia gravis.
- •4) Patients receiving the drug containing HIV protease inhibitors, efavirenz, or cobicistat.
- •5) Patients receiving St. John's wort supplement and are unable to discontinue taking the supplement from 1 week prior to the start of study drug administration up to 8 hours after the completion of study drug administration.
- •6) Patients with shock, coma, or acute alcohol intoxication with suppressed vital signs.
- •7) Patients with severe hepatic, renal, cardiovascular, gastrointestinal, or hematological disorders.
- •8) Patients using or expected to use artificial heart-lungs during the surgery.
- •9) Patients expected to receive blood transfusion during or after the surgery (up to 8 hours after completion of the study drug administration)
- •10) Patients with airway problems, such as upper airway stenosis including tonsillar hypertrophy, difficult airways, etc.
- •11) Patients with respiratory function disorder, such as lung disease, scoliosis, etc.
研究者
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