Pharmacokinetic study of single oral administration of Yokukansan (TJ-54) in healthy adults and elderly subjects.

Tsumura & Co.0 个研究点目标入组 22 人开始时间: 2019年1月30日最近更新: 2023年10月17日

试验速览

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•(1)Subjects whose body weight is less than 50.0 kg.
•(2)Subjects with a history of allergic reactions to drugs and foods.
•(3)Subjects who have participated in other clinical trial within the past 16 weeks starting from the hospitalization date (two days before test drug administration).
•(4)Subjects who have had their blood drawn or donated >400mL of blood within the past 12 weeks starting from the hospitalization date (two days before test drug administration).
•(5)Subjects with a history of significant respiratory or hepatic disease.
•(6)Subjects with a history of digestive disease. (peptic ulcer, reflux esophagitis etc.)(excepting for the history of appendicitis)
•(7)Subjects with a history of digestive tract resection. (excepting for appendicitectomy)
•(8)Subjects who cannot quit drinking or smoking from the hospitalization date (two days before test drug administration) to the end of the clinical trial.
•(9)Subjects who cannot interrupt drugs other than the test drug or supplements from 7 days before test drug administration to the end of the clinical trial.
•(10)Subjects with abnormal clinical laboratory values inappropriate for the study in the opinion of the principal investigator/subinvestigator.
•(11)Subjects who have positive HCV antibody, HBs antigen, HIV antigen antibody, TP antibody.
•(12)Subjects who are deemed ineligible for other reasons by the principal investigator/subinvestigator.

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