CTRI/2018/06/014355
Not yet recruiting
未知
A clinical study to determine the blood glucose response of Vidavance TM in healthy volunteers
Signutra Inc0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Signutra Inc
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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.
Outcomes
Primary Outcomes
Not specified
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