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:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT01952535
Eligibility Criteria:
Inclusion Criteria:
* Female and male volunteers, 18 to 45 years of age
* BMI: 18 to 24 kg/m2
* Fasting plasma glucose: 3.9 to 6.1 mmol/L
* Glucose level at 2 hours following oral glucose tolerance test \<7.8 mmol/L
* HbA1c: 4 to 6.5%
* Normal supine blood pressure and normal ECG recordings
Exclusion Criteria:
* Female with child-bearing potential
* Evidence of clinically-significant renal, cardiac, bronchopulmonary, vascular, gastrointestinal, allergic, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, cancer, hepatitis or cirrhosis.
* Intake of grapefruit or anything that may affect liver enzyme function within 1 month prior to the dosing day
* Clinically-relevant deviation from normal in the physical examination
* Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01952535
Study Brief:
Protocol Section:
NCT01952535