CTRI/2018/06/014355尚未招募未知
A clinical study to determine the blood glucose response of Vidavance TM in healthy volunteers
Signutra Inc0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1.Males or females in the age 18- 65 years (both inclusive).
- •2.Be of normal health as determined by the investigator from medical history, clinical and physical examination.
- •3.Random blood sugar level <= 200 mg/dl at screening.
- •4.BMI between 18.5 to 25 kg/m2 (both inclusive).
- •5.Must be willing to or likely to comply with all study requirements.
- •6.Must be able and willing to provide written informed consent.
- •7.Women of childbearing potential should have a negative pregnancy test at the time of screening and agree to use contraception during the study.
- •Exclusion criteria
- •Patients meeting any of the following exclusion criteria will not be eligible for participation in this trial:
- •1.Age less than 18yrs and greater than 65yrs
- •2.Previous history of any clinically significant medical condition e.g. cardiovascular, type 2 diabetes mellitus, eating disorder or serious gastrointestinal indications which in opinion of investigator may jeopardize subjectâ??s safety and preclude trial participation.
- •3.Use of antihyperglycemic drugs or insulin to treat diabetes and related conditions
- •4.Suffering from any condition which may interfere with nutrient absorption, distribution, metabolism and excretion in opinion of the Investigator e.g. subacute obstruction.
- •5.Current use of medication (eg steroids, protease inhibitors or antipsychotics, etc.) which may interfere with the digestion and nutrient absorption or affect glucose tolerance and estimation in opinion of the Investigator.
- •6.Abuse of drugs or alcohol.
- •7.Known case of sensitivity to Gluten or Coeliac disease.
- •8.Pregnant or lactating women.
- •9.Currently participating or had participated in any other interventional study in last 1 month prior to screening.
- •10.Patients who are unlikely to comply with protocol requirements (e.g. non-cooperative behavior, illiterate, inability to attend study visits required by the protocol).
排除标准
- •Patients meeting any of the following exclusion criteria will not be eligible for participation in this trial:
- •1.Age less than 18yrs and greater than 65yrs
- •2.Previous history of any clinically significant medical condition e.g. cardiovascular, type 2 diabetes mellitus, eating disorder or serious gastrointestinal indications which in opinion of investigator may jeopardize subjectâ??s safety and preclude trial participation.
- •3.Use of antihyperglycemic drugs or insulin to treat diabetes and related conditions
- •4.Suffering from any condition which may interfere with nutrient absorption, distribution, metabolism and excretion in opinion of the Investigator e.g. subacute obstruction.
- •5.Current use of medication (eg steroids, protease inhibitors or antipsychotics, etc.) which may interfere with the digestion and nutrient absorption or affect glucose tolerance and estimation in opinion of the Investigator.
- •6.Abuse of drugs or alcohol.
- •7.Known case of sensitivity to Gluten or Coeliac disease.
- •8.Pregnant or lactating women.
- •9.Currently participating or had participated in any other interventional study in last 1 month prior to screening.
- •10.Patients who are unlikely to comply with protocol requirements (e.g. non-cooperative behavior, illiterate, inability to attend study visits required by the protocol).
研究者
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