Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07466667
Eligibility Criteria:
Inclusion Criteria:
1)Age: 18 to 45 years (both inclusive) at the time of consent Sex: male and non-pregnant/non-lactating female. 3) Females of childbearing potential must have a negative urine pregnancy test performed on screening visits.
4\) Participants having fasting blood glucose levels less than 100 milligrams per decilitre.
5\) Participants with a Body Mass Index of 18.5 to 25 kilogram per meter square (both inclusive).
6\) Participant is in good general health as determined by the Investigator on the basis of medical history and vital signs.
7\) Participants should be willing and able to follow the study protocol to participate in the study.
8\) Participant must be able to understand and provide written informed consent to participate in the study.
9\) Participant is willing to refrain from vigorous physical exercise during the study period.
10\) Participants is willing to stay overnight as per study specification requirements.
Exclusion Criteria:
1. Participant has any known food allergy or intolerance to any food or beverages.
2. Participant is taking any medication in the past one week.
3. Participants should not be taking any medications known to affect glucose tolerance (excluding oral contraceptives) - stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable
4. Participants should not have any known food allergy or intolerance
5. Presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
6. Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study.
7. Participation in any similar clinical trial within the past 90 days with blood loss more than 450 millilitre.
8. An unusual diet, special diet, for whatever reason e.g. high protein diet, low sodium diet, for two weeks prior to receiving any test food and throughout the Participant's participation in the study.
9. Participant has performed vigorous physical exercise in the morning on dosing day.
10. Pregnant or lactating females.
11. Self-reported Positive Human Immunodeficiency Virus test.
12. History of Hepatitis B or C virus self-reported
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07466667
Study Brief:
Protocol Section:
NCT07466667