Healthy individual
Conditions
Interventions
Intervention type:DRUG
Name of intervention:ECM-E
Dose form / Japanese Medical Device Nomenclature:CAPSULE
Route of administration / Site of application:ORAL
Dose per administration:3000mg
Dosing freq
Sponsors
ADAPTGEN PHARMACEUTICAL CO.,LTD.
1,Medical institutions conduct clinical research
MEDOC Medical Dock&Clinic
2,CRO
Medical Fusion Co.,Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects of the experiment and the Japanese who meet the criteria for all of the following. 1) A person who is Japanese male and is between 40 and 65 years old at the time of Informed Consent. 2) A person whose blood pressure and body temperature are the following at this clinical trial and the screening. Blood pressure : Systolic 140mmHg less than Diastolic 90mmHg less than Body temperature:35.5-37.0dgrees 3) A person who is in the range of more than 15ng/mL and less than 50ng/mL in blood hyaluronic acid concentration. 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 is liver dysfunction is suspected in clinical laboratory values are as follows screening. a) T-Bil 3.0 or more b) GOT, GPT upper limit of normal multiply 2.5 or more (100) c) Al-P upper limit of normal multiply 2.5 or more d) gamma-GTP upper limit of normal multiply 1.5 or more e) LDH upper limit of normal multiply 1.5 or more 2) A person who with the disease to gastrointestinal tract, liver, kidney, the heart which have an influence on absorption, distribution, metabolism, the excretion. 3) 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. 4) A person who has a food allergy in chicken and a chicken egg or a chronic food allergy. 5) A person who has Mucopolysaccharidosis. 6) Person with alcohol or drug dependence. 7) 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. 8) The person who took other drugs for less than one week to start this clinical trial. 9) 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. 10) A person who can not keep the compliance rules of participation in clinical trials and report symptoms. 11) In addition, the person who identified as improper by the principal investigator or subinvestigators. 12) A women who is pregnant or breastfeeding.
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. | — |
Secondary
| Measure | Time frame |
|---|---|
| We check the amount of change and safety by a general blood test, biochemical examination and urinalysis | — |
Countries
Japan
Contacts
Public ContactHiromichi Hayashi
Medical Fusion CO.LTD.
Outcome results
None listed