Healthy volunteers
Conditions
Sponsors
Tsumura & Co.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics and safety | — |
Outcome results
None listed