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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00842556
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body mass index (BMI) of 18 to 32 kg/m2, inclusive BMI = weight (kg)/\[height(m)\]2
Exclusion Criteria:
* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
* Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN)
* History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
* History of allergy to SGLT@ inhibitors, DPP$ inhibitors or sulfonylurea or related compounds
* Prior exposure to dapagliflozin, sitagliptin and glimepiride within 3 months of Day -1
* History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00842556
Study Brief:
Protocol Section:
NCT00842556