JPRN-jRCT1091220179已完成Unknown
Verifying the control effects of glucose absorption through the comparison of SekirenB2 with a placebo in double blind cross over comparative study. - PRT-AD-MF-OGTT-SEKIREN-01-01
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •1)A person who is Japanese and between 20 and 65 years old at the time of informed consent.(Sex is not asked)
- •2)A person who has blood pressure and body temperature of the following value at this clinical trial and the screening.
- •Blood pressure:
- •Systolic Less than 140mmHg
- •Diastolic Less than 90mmHg
- •Body temperature: 35.5-37.0 degrees
- •3)A person whose HbA1c is applied to following either value.
- •a)HbA1c:6.4% or less
- •b)HbA1c:6.5% or more and less than 7.0%
- •4)A person must be received to explanation about the test food,objective of clinical test and side effects by clinical research investigator or sub investigator.
- •And the person who understood explanation well,agreed with written informed consent and desired participation in the clinical trial.
- •5)A person who can quit smoking on the day of clinical trial.
- •6)A person who can obey management manner in implementation medical institutions.
- •7)A person who can do screening test within 60 days of this clinical trials implementation and was qualified by clinical research investigator or sub clinical research investigator.
排除标准
- •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.
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