TJ-54 Pharmacokinetic study
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT1080221769
- Lead Sponsor
- Tsumura & Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 15
1)Subject body mass index (BMI) is between 18.5 and 25 kg/m2
2)Willing and able to provide written, signed informed consent
1) Subjects with a history of allergic reactions to drugs (including Kampo medicines) 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 serious hepatic, cardiovascular or hematological disease.
6) Subjects with hepatic steatosis.
7) Current physical dependence and habitual use of alcohol and/or tobacco products within 3 days prior to study drug administration at each treatment phase.
8) Long-term use of medications (e.g., antipsychotic, antifungal, antihypertensive, Kampo medicine, etc.).
9) Use of supplements containing Glycyrrhiza, Cnidium rhizome, Angelicae root, Bupleuri root, Uncaria hook, Atractylodis lancea rhizome, Poria Sclerotium 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 deemed 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics and safety assessment
- Secondary Outcome Measures
Name Time Method