Unique ID issued by UMIN | UMIN000031452 |
---|---|
Receipt number | R000035908 |
Scientific Title | A pharmacokinetics study of the major ingredient and its metabolites after single ingestion of test food |
Date of disclosure of the study information | 2018/02/26 |
Last modified on | 2018/04/03 17:04:17 |
A pharmacokinetics study of the major ingredient and its metabolites after single ingestion of test food
A pharmacokinetics study of food ingredients
A pharmacokinetics study of the major ingredient and its metabolites after single ingestion of test food
A pharmacokinetics study of food ingredients
Japan |
Not applicable
Not applicable |
Others
NO
Evaluation for the pharmacokinetics of food ingredients
Pharmacokinetics
Cmax
Tmax
AUC
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Oral intake of the test food on the day
30 | years-old | <= |
60 | years-old | >= |
Male
1) Age: 30 and over, below 60.
2) Sex: Japanese males
3) Understanding the study intent and purpose and submitting the written informed consent before study.
4) Subjects who are negative for HBs antigen/antibody, HCV antibody, HIV antigen/antibody, syphilis antigen tests.
1) Subjects who are in a continuing treatment with a prescription drug for over a month.
2) Subjects who intake of a prescription drug or an over-the-counter drug within a last week.
3) Subjects who does not meet the following clinical testing criteria; AST and ALT below 30 U/L, gamma-GTP below 50 U/L.
4) Subjects who are deemed to be unsuitable by the physician- in-charge.
5
1st name | |
Middle name | |
Last name | Masaaki Takehara |
Zenyaku Kogyo Co., Ltd.
Consumer Products Development and Licensing Section
6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo
+81-3-3946-1112
Masaaki_Takehara@mail.zenyaku.co.jp
1st name | |
Middle name | |
Last name | Takeshi Nagata |
Zenyaku Kogyo Co., Ltd.
Consumer Products Development and Licensing Section Consumer Healthcare Products Department
6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo
+81-3-3946-1112
Takeshi_Nagata@mail.zenyaku.co.jp
Zenyaku Kogyo Co., Ltd.
None
Self funding
HUMA R&D CORP
NO
とうきょうスカイツリー駅前内科(東京都)、全薬工業株式会社研究開発センター(東京都)/Tokyo Skytree Station Medical Clinic (Tokyo), Zenyaku Kogyo Research and Develop Center (Tokyo)
2018 | Year | 02 | Month | 26 | Day |
Unpublished
Completed
2018 | Year | 02 | Month | 08 | Day |
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 02 | Month | 23 | Day |
2018 | Year | 04 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035908
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |