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:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT07300020
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 tests, in the opinion of the investigator.
Non-smoker or light smoker (10 or fewer cigarettes per day or equivalent) willing to abstain from smoking during confinement periods, as determined by the investigator.
Able to understand and provide written informed consent before any study-specific procedures are performed.
Willing and able to comply with all study requirements, including fasting requirements, visit schedules, and pharmacokinetic blood sampling.
Females of childbearing potential must use acceptable contraception as determined by the investigator.
Exclusion Criteria:
* Known hypersensitivity or contraindication to metformin or any component of the study formulations.
History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disease that, in the opinion of the investigator, could interfere with study participation or interpretation of results.
Estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m², or any clinically significant abnormality in clinical laboratory tests.
History of lactic acidosis.
Use of any prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before the first study dose, unless considered acceptable 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 at admission to the clinical unit.
Participation in another clinical trial or receipt of an investigational drug or device within 30 days or 5 half-lives of the prior investigational product (whichever is longer) before the first study dose.
Donation of 450 mL or more 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 methods of contraception.
Any condition or circumstance that, in the opinion of the investigator, would make the subject unsuitable for the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07300020
Study Brief:
Protocol Section:
NCT07300020