jRCTs071230054已完成不适用
Effects of microbiome from probiotics and fermented foods on the pharmacokinetics of orally administered drugs
未提供0 个研究点目标入组 10 人开始时间: 2023年10月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- blood drug concentration
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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Basic Science
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •Japanese healthy male who is capable to understand and sign the informed consent
- •20-45 years of age
- •BMI 17.6-26.4
- •good health as determined by physical examination, vital signs and laboratory tests.
排除标准
- •history of allergy to any drugs
- •medical attention within 2 months prior to participation
- •donation of 200 mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation
- •donation of 400 mL or more of blood within 12 weeks prior to participation
- •recent (past 4 months) participation in other clinical trial for investigational new chemical entity
- •history of drug abuse
- •alcohol abuse
- •taking drugs or healthy foods which may affect drug metabolism
结局指标
主要结局
blood drug concentration
tacrolimus, valacyclovir, candesartan cilexetil and their major metabolites
pharmacokinetic parameters
Cmax, Tmax, AUC, T1/2, CL, etc.
次要结局
未报告次要终点
研究者
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