UMIN-CTR Clinical Trial

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

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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.


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



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 or person

Institute

ADAPTGEN PHARMACEUTICAL CO.,LTD.

Institute

Department

Personal name



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

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