JPRN-jRCT1080221769未知1 期
Pharmacokinetic study of single oral administration of yokukansan(TJ-54) in healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 15
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
- >= 20age old 至 <= 44age old（—）
- 性别
- All
入选标准
- •1)Subject body mass index (BMI) is between 18.5 and 25 kg/m2
- •2)Willing and able to provide written, signed informed consent
排除标准
- •1) Subjects with a history of allergic reactions to drugs (including Kampo medicines) and food(s).
- •2) Female subjects who are pregnant, breastfeeding or planning to become pregnant.
- •3) Subjects who have participated in another clinical trial within 16 weeks prior to study drug administration.
- •4) Subjects who have had their blood drawn or donated > 400mL of blood within 12 weeks prior to study drug administration.
- •5) Subject with history of serious hepatic, cardiovascular or hematological disease.
- •6) Subjects with hepatic steatosis.
- •7) Current physical dependence and habitual use of alcohol and/or tobacco products within 3 days prior to study drug administration at each treatment phase.
- •8) Long-term use of medications (e.g., antipsychotic, antifungal, antihypertensive, Kampo medicine, etc.).
- •9) Use of supplements containing Glycyrrhiza, Cnidium rhizome, Angelicae root, Bupleuri root, Uncaria hook, Atractylodis lancea rhizome, Poria Sclerotium within 3 days prior to study drug administration.
- •10) Use of any agent within 7 days prior to study drug administration at each stage of the study.
- •11) Subjects with abnormal clinical laboratory values inappropriate for the study in the opinion of the principal investigator/subinvestigator at screening or on the day before study drug administration.
- •12) Subjects who are deemed ineligible for other reasons by the principal investigator/subinvestigator.
- •13) The subject has a positive test result for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C or human immunodeficiency virus (HIV).
研究者
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