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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000023609 |
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Date of registration:
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12/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pharmacokinetic and Metabolic Analysis of Maoto
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Scientific title:
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Pharmacokinetic and Metabolic Analysis of Maoto - Pharmacokinetic and Metabolic Analysis of Maoto |
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Date of first enrolment:
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2016/08/12 |
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Target sample size:
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4 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027186 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hiroyuki Kitagawa |
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Address:
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Kohasu-Okocho, Nankoku, Kochi 783-8505, Japan
Japan |
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Telephone:
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088-866-5811 |
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Email:
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im31@kochi-u.ac.jp |
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Affiliation:
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Kochi Medical School Department of Surgery, Kochi Medical School |
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Name:
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Kazuhiro hanazaki |
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Address:
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Department of Surgery, Kochi Medical School, Kohasu-Okocho, Nankoku, Kochi 783-8505, Japan
Japan |
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Telephone:
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088-866-5811 |
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Email:
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im31@kochi-u.ac.jp |
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Affiliation:
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Kochi Medical School Department of Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
20years-old
Age maximum:
45years-old
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy adult
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Intervention(s)
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Moat (TJ-27)
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Primary Outcome(s)
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Detect of ingredients delivers from Maoto in plasma.
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Secondary Outcome(s)
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Calculation of PK parameters and detect of ingredients delivers from Maoto in urine.
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Source(s) of Monetary Support
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Japan Agency for Medical Research and Development
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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