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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023609
Receipt No. R000027186
Scientific Title Pharmacokinetic and Metabolic Analysis of Maoto
Date of disclosure of the study information 2016/08/12
Last modified on 2017/02/15

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Basic information
Public title Pharmacokinetic and Metabolic Analysis of Maoto
Acronym Pharmacokinetic and Metabolic Analysis of Maoto
Scientific Title Pharmacokinetic and Metabolic Analysis of Maoto
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuhiro hanazaki
Organization Kochi Medical School
Division name Department of Surgery
Zip code
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
1st name
Middle name
Last name Hiroyuki Kitagawa
Organization Kochi Medical School
Division name Department of Surgery, Kochi Medical School
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 07 Month 25 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000027186

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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