UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacokinetic and Metabolic Analysis of Maoto
Title of the study (Brief title)	Pharmacokinetic and Metabolic Analysis of Maoto
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the exposure and pharmacokinetics of the ingredients of Maoto in healthy volunteers.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detect of ingredients delivers from Maoto in plasma.
Key secondary outcomes	Calculation of PK parameters and detect of ingredients delivers from Maoto in urine.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Moat (TJ-27)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	45 years-old >=
Gender	Male
Key inclusion criteria	(1) Japanese (2) Male (3) Age: 20 ~ 45 (4) BMI: 18.5 ~ 25.0 (5) Informed consent
Key exclusion criteria	(1) Allergy (2) Prticipate to other clinical trials within 16 weeks (3) Blood donation more than 400 ml within 12 weeks (4) Severe liver, heart or blood disease (5) Alchol and smooking (6) Drugs (7) Supllyments or diets which contains the ingredients of Maoto (8) Diagnosed as inappropriate by doctor (9) Positive HCV antibody, HBs antigen, and HIV antibody (10) Use of amphetamine and methamphetamine
Target sample size	4

Research contact person
Name of lead principal investigator	Kazuhiro hanazaki
Organization	Kochi Medical School
Division name	Department of Surgery
Address	Department of Surgery, Kochi Medical School, Kohasu-Okocho, Nankoku, Kochi 783-8505, Japan
TEL	088-866-5811
Email	im31@kochi-u.ac.jp

Public contact
Name of contact person	Hiroyuki Kitagawa
Organization	Kochi Medical School
Division name	Department of Surgery, Kochi Medical School
Address	Kohasu-Okocho, Nankoku, Kochi 783-8505, Japan
TEL	088-866-5811
Homepage URL
Email	im31@kochi-u.ac.jp

Sponsor
Institute	Kochi Medical School
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tsumura & Co.
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 25 Day
Anticipated trial start date	2016 Year 08 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 12 Day
Last modified on	2017 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027186