Healthy volunteers
Conditions
Interventions
investigational material(s)
Generic name etc : TJ-43 [Tsumura Rikkunshito Extract Granules for prescription]
INN of investigational material :
Therapeutic category code : 52- Chinese medicines
Dosag
Sponsors
Tsumura & Co.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subject body mass index (BMI) is between 18.5 and 25 kg/m2 2)Willing and able to provide written, signed informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects with a history of allergic reactions to drugs 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 significant hepatic, cardiovascular or hematological disease. 6) Subjects with hepatic steatosis. 7) Subjects who can not give up smoking and drinking alcohol at a hospitalization time to the end of test. 8) Subject who can not stop using any medicine (e.g., antipsychotic, antifungal, antihypertensive, Kampo medicine, etc.) from 7 days prior to trial drug medication to that. 9) Use of supplements containing JP Atractylodes Lancea Rhizome, JP Ginseng, JP Pinellia Tuber, JP Poria Sclerotium, JP Jujube, JP Citrus Unshiu Peel, JP Glycyrrhiza, JP Ginger.(JP: The Japanese Pharmacopoeia) 10) Use of any agent within 7 days prior to study drug administration. 11) Subjects with abnormal clinical laboratory values inappropriate for the study in the opinion of the principal investigator/subinvestigator. 12) Subjects who are deemed ineligible for other reasons by the principal investigator/subinvestigator. 13) Subjects who have positive HCV antibody, HBs antigen, HIV antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and safety assessment | — |
Outcome results
None listed