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 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT07300059
Eligibility Criteria:
Inclusion Criteria:
\- Male or female adults 18 to 55 years of age, inclusive.
Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.
Medically healthy based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator.
Fasting blood glucose within the normal reference range at screening.
Non-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during each study confinement period.
Able to understand and provide written informed consent before participation.
Willing and able to comply with all study procedures, including fasting requirements, glycemic assessments, and timed blood draws.
Females of childbearing potential must use acceptable contraception as determined by the investigator.
Exclusion Criteria:
* Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.
History or presence of any clinically significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric condition that, in the investigator's judgment, could interfere with study participation or data interpretation.
Fasting blood glucose outside the normal reference range at screening, or any history of hypoglycemia or glucose regulation disorders.
Estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m² or any clinically significant abnormal clinical laboratory results.
History of lactic acidosis.
Use of prescription medications, over-the-counter medications, vitamins, herbal supplements, or dietary supplements within 14 days before first study dosing, unless approved by the investigator.
Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.
Positive urine drug screen or positive alcohol breath test at screening or admission.
Participation in another clinical study or receipt of an investigational product within 30 days or 5 half-lives (whichever is longer) before the first study dose.
Donation of ≥450 mL of blood, or significant blood loss, within 8 weeks before the first study dose.
Pregnant or breastfeeding females.
Women of childbearing potential not using acceptable contraception.
Any condition that, in the opinion of the investigator, would make the participant unsuitable for the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07300059
Study Brief:
Protocol Section:
NCT07300059