Verifying the control effects of glucose absorption through the comparison of SekirenB2 with a placebo in double blind cross over comparative study.

UMIN ID: UMIN000014000

Registered date:26/05/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy individual
• Date of first enrollment: 2014/05/26
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

SekirenB2
Placebo

Outcome(s)

• Primary Outcome: We decide the value in front of test food ingestion start is standard and it is 0 hour. We check the amount of change of the blood glucose level after ingesting test food and measure the level in 0.5, 1, 1.5, 2, 2.5, 3, 4 hours later.
• Secondary Outcome: We decide the value in front of test food ingestion start is standard and it is 0 hour. We check the amount of change of theblood test item and the urinalysis item 4 hours later.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1)A person who is suspected to have an impaired liver function on result of clinical laboratory test at the screening. a) T-Bil 3.0 or more b) GOT,GPT More than normalcy upper limit multiply 2.5(100 or more) c) A1-P More than normalcy upper limit multiply 2.5 d) gamma-GTP More than normalcy upper limit multiply 1.5 e) LDH More than normalcy upper limit multiply 1.5 2)A person who has disease of gastrointestinal tract, kidney and the heart which have an influence on absorption, distribution, metabolism and the excretion. 3)A person who has surgical history of gastrointestinal tract site. For example gastrectomy, stomach and intestines suture, intestinal tract resection and so on. 4)A person who has food allergy. 5)A person who has alcohol or drug dependence. 6)A person who treated diabetes within 3 months at the time of obtaining informed consent. 7)A person who participated in other clinical study of new drug or received medical treatment within 3 months at the time of obtaining informed consent. 8)A person who take other medicine from less than one week to start this clinical trial. 9)A person who has taken the whole blood bleeds or ingredient blood collecting (plasma or plaque component blood collecting) 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't obey management manner or can't report about subjective symptoms during participation in clinical trials. 11)In addition a person who is identified as improper by the responsibility researcher or subresponsibility researcher. 12)A woman who is pregnant or breastfeeding.

Related Information

• Primary Sponsor: ADAPTGEN PHARMACEUTICAL CO.,LTD.
• Secondary Sponsor: 1,Medical institutions conduct clinical research MEDOC Medical Dock&Clinic 2,CRO Medical Fusion Co.,Ltd.
• Source(s) of Monetary Support: ADAPTGEN PHARMACEUTICAL CO.,LTD.