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Recruitment status Completed
Unique ID issued by UMIN UMIN000011718
Receipt No. 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

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Basic information
Public title Hyaluronic acid pharmacokinetics study of ECM-E
Acronym Hyaluronic acid pharmacokinetics study of ECM-E
Scientific Title Hyaluronic acid pharmacokinetics study of ECM-E
Scientific Title:Acronym Hyaluronic acid pharmacokinetics study of ECM-E
Region
Japan

Condition
Condition Healthy male subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes 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.
Key secondary outcomes 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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Medicine Food
Interventions/Control_1 ECM-E
Intake:3000mg
Ingestion period:1day
Interventions/Control_2 ECM-E
Intake:1200mg
Ingestion period:1day
Interventions/Control_3 Placebo
Intake:3000mg
Ingestion period:1day
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >=
Gender Male
Key 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.
Key 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.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigehiro Kure
Organization Sanbongi Clinic
Division name Clinic Director
Zip code
Address 2-1, Hosohazama, Sambongi-cho, Nisshin-shi, Aichi, 470-0101, Japan
TEL 0561-56-4532
Email shigehiro_kure@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromichi Hiromichi
Organization Medical Fusion Co.,Ltd.
Division name Clinical Development Division
Zip code
Address Nagoya Life Science Incubator, 2-22-8, Chikusa, Chikusa-ku, Nagoya, Aichi, 464-0858, Japan
TEL 052-745-3300
Homepage URL
Email info@m-fusion.co.jp

Sponsor
Institute ADAPTGEN PHARMACEUTICAL CO.,LTD.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization ADAPTGEN PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor 1,Medical institutions conduct clinical research
MEDOC Medical Dock&Clinic
2,CRO
Medical Fusion Co.,Ltd.
Name of secondary funder(s) Shachihata Inc,.
Provision of "PC approval"management software and electronic seal

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 JMA-IIA00141
Org. issuing International ID_1 JMACCT CTR
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人メドック健康クリニック(愛知県)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 14 Day
Last follow-up date
2013 Year 10 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 11 Day
Last modified on
2017 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013700


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