UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023609 |
|---|---|
| Receipt number | 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 14:23:01 |
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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
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
im31@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
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
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
Value
https://center6.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 |
