臨床研究等提出・公開システム

Date of registration	Mar. 25, 2021
Last modified on	April. 05, 2021
Trial ID	jRCT2031200439

Scientific Title	Pharmacokinetic study of single oral administration of Ninjin'yoeito(TJ-108) in healthy adults.
Public Title	Pharmacokinetic study of single oral administration of Ninjin'yoeito.

Contact for Scientific Queries	Name	Orimoto Mie
	Affiliation	Tsumura & Co.
	Address	17-11 Akasaka 2-Chome, Minato-ku, Tokyo
	Telephone	+81-80-4408-6108
	E-mail	orimoto_mie@mail.tsumura.co.jp
Contact for Public Queries	Name	Tsumura & Co. Research & Development administration department
	Affiliation	Tsumura & Co.
	Address	17-11 Akasaka 2-Chome, Minato-ku, Tokyo
	Telephone	+81-80-4408-6108
	E-mail	orimoto_mie@mail.tsumura.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Mar. 12, 2021
Actual date of first enrollment		Mar. 12, 2021
Target sample size		8
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	(1)Japanese (2)Subjects body mass index is between 18.5 and 25.0. (3)Willing and able to provide written, signed informed concent.
	Exclusion Criteria	(1)Subjects with a history of allergic reactions to drugs and foods. (2)Subjects who have participated in other clinical trial within the past 16 weeks starting from the hospitalization date (two days before test drug administration). (3)Subjects who have had their blood drawn or donated >200mL of blood within the past 12 weeks starting from the hospitalization date (two days before test drug administration). (4)Subjects with a history of significant organopathy. (5)Subjects with a history of digestive disease. (peptic ulcer, reflux esophagitis etc.)(excepting for the history of appendicitis) (6)Subjects with a history of digestive tract resection. (excepting for appendicitectomy) (7)Subjects who cannot quit drinking or smoking from the hospitalization date (two days before test drug administration) to the leaving hospital. (8)Subjects who cannot interrupt drugs other than the test drug or supplements from 7 days before test drug administration to the end of the clinical trial. (9)Subjects with abnormal clinical laboratory values inappropriate for the study in the opinion of the principal investigator/subinvestigator. (10)Subjects who have any of positive HCV antibody, HBs antigen, HIV antigen antibody, TP antibody. (11)Subjects who are deemed ineligible for other reasons by the principal investigator/subinvestigator.
	Age Minimum	20age old over
	Age Maximum	45age old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		fatigue,poor appetite etc.
Intervention(s)		Oral administration of Ninjin'yoeito
Primary Outcome(s)		Pharmacokinetics (Glycyrrhetinic acid etc.)
Secondary Outcome(s)		Pharmacokinetics (Other than primary outcome.)

Primary Sponsor	Tsumura & Co.

Name of Certified Review Board	IRB of Medical Corporation Shinanokai, Shinanozaka Clinic
Address	Yotsuya Medical Building, 20 Samon-cho, Shinjyuku-ku, Tokyo
Telephone	+81-3-5366-3006
E-Mail	h-ogura@trcp.co.jp
Approval Status	Approval
Date of approval	Feb. 09, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 05, 2021	(this page)	Changes
1	Mar. 25, 2021	Detail

List of change history