JPRN-jRCT1080222472未知1 期
Pharmacokinetic study of single oral administration of rikkunshito (TJ-43) in healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 21
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)Japanese
- •2)Subject body mass index (BMI) is between 18.5 and 25 kg/m2
- •3)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 foods).
- •2)Female subjects who are pregnant, breastfeeding or planning to become pregnant.
- •3)Subjects who have participated in anothor clinical traial 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 under treatment.
- •7)Current physical dependence and habitual use of alcohol and/or tabacco products within 3 days prior to study drug administration at each treatment phase.
- •8)Long-term use of medicications (e.g., antipsychotic, antifungal, antihypertensive, Kampo medicine, etc.).
- •9)Use of supplements containing Atractylodis lanceae rhizoma, Ginseng radix, Pinellia tuber, Hoelen, Zizyphi fructus, Aurantii nobilis pericarpium, Glycyrrhizae radix, Zingiberis rhizoma and vitamin P 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 deems 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
相似试验
未知
1 期
TJ-100 Pharmacokinetic studyHealthy volunteersJPRN-jRCT1080221080Tsumura & Co.15
未知
1 期
TJ-54 Pharmacokinetic studyHealthy volunteersJPRN-jRCT1080221769Tsumura & Co.15
已完成
1 期
Pharmacokinetic study of single oral administration of Maobushisaishinto.JPRN-jRCT1080225096Tsumura & Co.8
进行中（未招募）
1 期
Pharmacokinetic study of single oral administration of Ninjin'yoeito.fatigue,poor appetite etc.JPRN-jRCT2031200439Orimoto Mie8
已完成
1 期
TJ-54 pharmacokinetic studyJPRN-jRCT1080224536Tsumura & Co.22