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

JRCT ID: jRCTs061210011

Registered date:08/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 01/06/2021
• Target sample size: 22
• Study type: Interventional
• Intervention(s): A single oral administration of yokukansan (2.5 g)

Outcome(s)

• Primary Outcome: Correlation 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
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Hanazaki Kazuhiro
• Secondary Sponsor: TSUMURA & CO.