NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061210011

Registered date:08/06/2021

Exploratory study of the stool metabolic activity of Yokukansan ingredient and the pharmacokinetics of its metabolite.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHealthy volunteers
Date of first enrollment01/06/2021
Target sample size22
Countries of recruitment
Study typeInterventional
Intervention(s)A single oral administration of yokukansan (2.5 g)

Outcome(s)

Primary OutcomeCorrelation between fecal bioactivity of glycyrrhizin (GL) and pharmacokinetic parameters of serum GA (Cmax and Tmax)
Secondary Outcome(1) Stool GL metabolic activity (2) Gut microbiota (3) Correlation between stool GL metabolic activity and gut microbiota (4) Correlation between Pharmacokinetic parameters of serum GA (Cmax and Tmax) and gut microbiota of the second stool correction data. (5) Comparison of gut microbiota in each enterotype (6) Comparison of GA pharmacokinetic parameters in each enterotype (7) Comparison of stool GL metabolic activity in each enterotype (8) Correlation between stool GL metabolic activity and gut microbiota in each enterotype. Description (1),(2); Investigation of individual diversity and stability using the first and second stool collections. (3); Investigation of correlation using the first and second stool collections. (4); Investigation of correlation using the second stool collections. (5); Comparison of intra-individual stability of enterotype estimated from the first and second stool collections. (6),(7); Comparison of GA pharmacokinetic parameters and stool GL metabolic activity in each enterotype estimated from the second stool collections. (8); Correlation between GA pharmacokinetic parameters and gut microbiota in each enterotype estimated from the first and second stool corrections.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 45age old
GenderBoth
Include criteria1. 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
Exclude criteria1. 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

Related Information

Contact

Public contact
Name Kohei Jobu
Address 185-1 Kohasu, Oko-cho, Nankoku-shi, Kochi Kouchi Japan 783-8505
Telephone +81-88-880-2549
E-mail jm-kouheij@kochi-u.ac.jp
Affiliation Kochi Medical School Hospital
Scientific contact
Name Kazuhiro Hanazaki
Address 185-1 Kohasu, Oko-cho, Nankoku-shi, Kochi Kouchi Japan 783-8505
Telephone +81-88-880-2203
E-mail hanazaki@kochi-u.ac.jp
Affiliation Kochi Medical School Hospital