Unique ID issued by UMIN | UMIN000032818 |
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Receipt number | R000037417 |
Scientific Title | Brazilian Green Propolis pharmacokinetics study in healthy volunteers |
Date of disclosure of the study information | 2018/09/30 |
Last modified on | 2018/12/19 16:54:40 |
Brazilian Green Propolis pharmacokinetics study in healthy volunteers
Brazilian Green Propolis pharmacokinetics study in healthy volunteers
Brazilian Green Propolis pharmacokinetics study in healthy volunteers
Brazilian Green Propolis pharmacokinetics study in healthy volunteers
Japan |
Adult
Adult |
Others
NO
We confirm pharmacokinetics of Propolis metabolites after intake of Propolis.
PK,PD
Exploratory
We confirm pharmacokinetics of Propolis metabolites by measuring a blood level of the metabolites before and 0.5,1,1.5,2,4,8,12,24 h after intake of Propolis.
We confirm safety by integrating adverse events, physiological examination, hematological examination, blood biochemical examination, and urinalysis (Measuring before and 24 h after intake of Propolis.).
Interventional
Cross-over
Non-randomized
Open -no one is blinded
Dose comparison
2
Prevention
Food |
Brazilian Green Propolis containing food(1)
Intake: 1,275mg
Ingesion:once
Brazilian Green Propolis containing food(2)
Intake:1,425mg
Ingesion:once
20 | years-old | <= |
45 | years-old | >= |
Male and Female
The subjects who meet all of the following criteria are included in this study.
1) Healthy Japanese
2) Males and females from 20 to 45 years old (at the time of consent acquisition)
3) BMI 18.5-25.0
4) Volunteers who is capable to understand and sign the informed consent
The subjects in conflict with any of the following condition are excluded.
1) A person who has a previous history of allergy
2) A person who has a previous history of asthma
3) A woman who is pregnant, hope for the pregnancy, or breastfeeding
4) A person who participated in other clinical trial within 12 weeks prior to ingestion of experimental diet
5) A person who has a positive reaction on the trial for infectious disease at screening
6) A person with a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, stomach and intestines suturation, intestinal tract resection and so on. (not included appendectomy)
7) A person who has a disease of liver, kidney and heart, diabetes and serious desease
8) A person who has received medical treatment of drug
9) A person who can not visit the designated inspection date (including the previous night) and be hospitalized until the end of a trial.
10) A person who can not quit eating and drinking excluding the designated food the day before the trial to the end of a trial.
11) A person who can not quit smoking from dinner the day before the trial to the end of a trial.
12) A person who cannot take in experimental diet according to instruction or cannot maintain rest until the end of a trial.
13) A person who can not ban the intake of propolis containing food within one week prior to the clinical trial.
14) A person who cannot keep regular hours
15) A person who is not daily service (who is night duty or rotating shift)
16) A person who has taken a blood sample (such as blood donation) of more than 200 mL within 4 weeks or more than 400 mL within 3 months prior to the start of this trial
17) A person who is a heavy alcohol drinker (over 500 mL per day in beer)
18) A person who is a heavy smorker (over 20 cigarettes per day)
19) A person who are judged inappropriate as the subject by the principal investigator or subinvestigators.
10
1st name | |
Middle name | |
Last name | Masayuki Sugimoto |
Medical corporation Koganeibasi Sakura Clinic
Not applicable
2-11-25 Sakuramachi, Koganei-city, Tokyo, 184-0005, Japan
042-382-5101
info@kb-clinic.com
1st name | |
Middle name | |
Last name | Hidenori Matsuzaki |
Yamada Bee Company, Inc.
Institute for Bee Products & Health Science
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
0868-54-3825
hm1380@yamada-bee.com
Yamada Bee Company, Inc.
Yamada Bee Company, Inc.
Profit organization
Research Center for Immunological Analysis. Inc.
NO
2018 | Year | 09 | Month | 30 | Day |
Unpublished
Completed
2018 | Year | 05 | Month | 30 | Day |
2018 | Year | 06 | Month | 13 | Day |
2018 | Year | 05 | Month | 31 | Day |
2018 | Year | 12 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037417
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