jRCT2031220678已完成不适用
Clinical Pharmacology Study -Drug-Drug Interaction Study of CNT-01-
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Crossover Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 40age old under(—)
- 性别
- Male
入选标准
- •Subjects who have signed the written informed consent.
- •Subjects 18 to 40 years of age at time of informed consent.
- •Subjects with body weight >=50 kg and body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive) at the Screening Visit.
排除标准
- •Subjects with complications or past history of medically significant gastrointestinal, renal, respiratory, endocrine, hematological, nervous system, psychiatric, cardiovascular, or congenital metabolic disorders.
- •Subjects with acute illness within 2 weeks prior to administration of the drugs used in the Clinical Trial.
- •Subjects with a current or past history of drug or food allergy.
- •Subjects whose serum potassium or magnesium levels are below the institutional normal ranges at the Screening Visit.
- •Subjects whose serum calcium level is above the institutional normal range at the Screening Visit.
- •Subjects whose serum thyroid stimulating hormone, free triiodothyronine, or thyroxine levels are above the institutional normal ranges at the Screening Visit.
- •Subjects with a history of infection requiring treatment within 4 weeks prior to administration of the drugs used in the Clinical Trial.
- •Subjects with a positive SARS-CoV-2 test (nucleic acid amplification test) performed within 3 days before admission to the clinical site or suspected COVID-19 infection.
结局指标
主要结局
-
Pharmacokinetics
次要结局
未报告次要终点
研究者
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