Healthy male subjects
Conditions
Interventions
ECM-E Intake:3000mg Ingestion period:1day
ECM-E Intake:1200mg Ingestion period:1day
Placebo Intake:3000mg Ingestion period:1day
Sponsors
ADAPTGEN PHARMACEUTICAL CO.,LTD.
1,Medical institutions conduct clinical research MEDOC Medical Dock&
Clinic 2,CRO Medical Fusion Co.,Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactHiromichi Hiromichi
Medical Fusion Co.,Ltd. Clinical Development Division
Outcome results
None listed