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临床试验/jRCT2031220678
jRCT2031220678已完成不适用

Clinical Pharmacology Study -Drug-Drug Interaction Study of CNT-01-

TOA EIYO LTD.0 个研究点目标入组 32 人开始时间: 2023年3月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
TOA EIYO LTD.
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

发起方
TOA EIYO LTD.

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