Exploratory study of the stool metabolic activity of Yokukansan ingredient and the pharmacokinetics of its metabolite.
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCTs061210011
- Lead Sponsor
- Hanazaki Kazuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 22
1. Japanese
2. Age 20 to 45 years old at the signing of infromed consent
3 BMI within the range 17 to 27
4. Written informed consent
1. Having a history of drug allergies or food allergies
2. Pregnant woman, wishing to become pregnant, or breastfeeding
3. Participated in other clinical studies within 16 weeks
4. Collected or donated blood more than 400 mL within 12 weeks for men and 16 weeks for women
5. Having a history of serious liver disease, heart disease or blood disease
6. Those who cannot continue quit smoking from 2 days before administration of the test drug
7. Those who cannot stop drinking, and/or taking licorice / licorice-containing foods and drinks (including spices), and licorice-derived supplements from 7 days before administration of the test drug
8. Judged by doctors not to be suited for the study based on the results of screening tests and the tests the day before administration of the test drug
9. Positive for HCV antibody, HBs antigen, or HIV antigen
10. Refused virus testing
11. Judged by doctors not to be suited for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between fecal bioactivity of glycyrrhizin (GL) and pharmacokinetic parameters of serum GA (Cmax and Tmax)
- Secondary Outcome Measures
Name Time Method