Unique ID issued by UMIN | UMIN000011718 |
---|---|
Receipt number | R000013700 |
Scientific Title | Hyaluronic acid pharmacokinetics study of ECM-E |
Date of disclosure of the study information | 2013/09/12 |
Last modified on | 2017/09/08 16:06:38 |
Hyaluronic acid pharmacokinetics study of ECM-E
Hyaluronic acid pharmacokinetics study of ECM-E
Hyaluronic acid pharmacokinetics study of ECM-E
Hyaluronic acid pharmacokinetics study of ECM-E
Japan |
Healthy male subjects
Adult |
Others
NO
We confirm blood kinetics of the hyaluronic acid after the ECM-E (hyaluronic acid made from a cockscomb) intake.
After ECM-E intake, a blood level of the hyaluronic acid is measured in 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0 hours later.
Pharmacokinetics
Exploratory
Phase I
We confirm blood kinetics of the hyaluronic acid after the ECM-E (hyaluronic acid made from a cockscomb) intake.
After ECM-E intake, a blood level of the hyaluronic acid is measured in 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0 hours later.
We confirm safety by a general blood test, a biochemical test, urinalysis.
After ECM-E intake, we give test mentioned above 0, 4, 8 hours later.
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Placebo
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Numbered container method
3
Diagnosis
Medicine | Food |
ECM-E
Intake:3000mg
Ingestion period:1day
ECM-E
Intake:1200mg
Ingestion period:1day
Placebo
Intake:3000mg
Ingestion period:1day
20 | years-old | <= |
40 | years-old | >= |
Male
The subjects for the experiment must be healthy male subjects who meets all the following standards.
1) A person who is Japanese male and is between 20 and 40 years old at the time of Informed Consent.
2) A person who is in the range of more than 18.5 and less than 25 in BMI(standard value (22)), based on the diagnostic criteria of the Japan Society for the Study of Obesity at this clinical trial and the screening.
BMI(Body Mass Index) = Weight(kg) / (Height(m))2
3) A person whose blood pressure, pulse and body temperature are the following at this clinical trial and the screening.
Blood pressure :
Systolic 130mmHg less than
Diastolic 85mmHg less than
Pulse:50-100 time/minute
Body temperature:35.5-37.0degrees
4) A person who received a full explanation about the expected objectives of the test food and the clinical test and the side effects at the screening from clinical research investigator (or subinvestigators), and agreed on the application with written informed consent for this clinical trial spontaneously upon well understanding.
5) The person who can discontinue smoking on the clinical trials day
6) A person who can comply with the management issues in the implementation medical institutions.
7) The person who was qualified by principal investigator or sub investigator in the screening test within 60 days of this clinical trials implementation.
The subjects in conflict with any of the following condition are excluded.
1) A person who with the disease to gastrointestinal tract, liver, kidney, the heart which have an influence on absorption, distribution, metabolism, the excretion.
2) 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.
3) A person who has a food allergy in chicken and a chicken egg or a chronic food allergy.
4) A person who has Mucopolysaccharidosis.
5) Person with alcohol or drug dependence.
6) A person who has participated in other clinical study or received medical treatment of new drug within 3 months at the time of obtaining informed consent.
7) The person who took other drugs for less than one week to start this clinical trial.
8) A person who has taken the whole blood bleeds or apheresis(plasma apheresis and platelet apheresis) more than 200mL within 3 months at the time of obtaining informed consent or during the period between the time of obtaining informed consent and this clinical trial implementation.
9) A person who can not keep the compliance rules of participation in clinical trials and report symptoms.
10) In addition, the person who identified as improper by the principal investigator or subinvestigators.
15
1st name | |
Middle name | |
Last name | Shigehiro Kure |
Sanbongi Clinic
Clinic Director
2-1, Hosohazama, Sambongi-cho, Nisshin-shi, Aichi, 470-0101, Japan
0561-56-4532
shigehiro_kure@yahoo.co.jp
1st name | |
Middle name | |
Last name | Hiromichi Hiromichi |
Medical Fusion Co.,Ltd.
Clinical Development Division
Nagoya Life Science Incubator, 2-22-8, Chikusa, Chikusa-ku, Nagoya, Aichi, 464-0858, Japan
052-745-3300
info@m-fusion.co.jp
ADAPTGEN PHARMACEUTICAL CO.,LTD.
ADAPTGEN PHARMACEUTICAL CO.,LTD.
Profit organization
Japan
1,Medical institutions conduct clinical research
MEDOC Medical Dock&Clinic
2,CRO
Medical Fusion Co.,Ltd.
Shachihata Inc,.
Provision of "PC approval"management software and electronic seal
YES
JMA-IIA00141
JMACCT CTR
医療法人メドック健康クリニック(愛知県)
2013 | Year | 09 | Month | 12 | Day |
Unpublished
Completed
2013 | Year | 03 | Month | 15 | Day |
2013 | Year | 09 | Month | 14 | Day |
2013 | Year | 10 | Month | 05 | Day |
2013 | Year | 09 | Month | 11 | Day |
2017 | Year | 09 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013700
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |