Healthy adults and elderly subjects
Conditions
Interventions
investigational material(s)
Generic name etc : TSUMURA Yokukansan Extract Granules for Ethical Use
INN of investigational material : -
Therapeutic category code : 52- Chinese medicines
Dosage and Admi
Sponsors
Tsumura & Co.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1)Japanese (2)Subjects body mass index is between 18.5 and 25.0. (3)Willing and able to provide written, signed informed concent.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety exploratory pharmacokinetics Guaisocidin methyl ether (GM),Glycyrrhetinic acid (GA) | — |
Secondary
| Measure | Time frame |
|---|---|
| exploratory pharmacokinetics other Plasma concentration transitions and metabolomes (target, non-target) of TJ-54-derived compounds other than GM and GA. | — |
Countries
Japan
Outcome results
None listed