A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults: Fed State Study

Launched by AJU PHARM CO., LTD. · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and how the body processes three diabetes medicines—dapagliflozin, linagliptin, and metformin—when taken together with food. The goal is to understand how these drugs behave in healthy adults, which helps researchers learn more about their effects before testing in people with type 2 diabetes.

Healthy adults between the ages of 19 and 50 who meet certain health and weight requirements may be eligible to participate. Participants should not have any serious health problems or be taking medications that could interfere with the study. During the trial, volunteers will take the medicines with meals, and doctors will monitor their health closely through tests and physical exams. It’s important to know this study is just beginning and is currently not recruiting volunteers yet. If you’re healthy and interested, the study team will explain everything and ask for your permission before joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy adult volunteers aged 19 to 50 years at the time of screening.
• • Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.
• • Male subjects must weigh ≥50 kg.
• • Female subjects must weigh ≥45 kg.
• • No clinically significant congenital or chronic diseases requiring treatment, based on medical history and physical examination.
• • Clinically acceptable results from laboratory tests (e.g., hematology, biochemistry, serology, urinalysis) and electrocardiogram (ECG) at screening, as determined by the investigator.
• • Willing to use medically accepted contraception (excluding hormonal methods) from the first dose until 7 days after the last dose, and agrees not to donate sperm or eggs during this period.
• • Able and willing to provide written informed consent after receiving a full explanation of the study.
• Exclusion Criteria:
• • Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.
• • Participation in any clinical trial involving investigational products within 6 months prior to the first dose.
• • Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose.
• • History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).
• * History of excessive alcohol consumption within 1 month prior to the first dose:
• • \>21 drinks/week for males, \>14 drinks/week for females (1 drink = 50 mL soju, 30 mL whiskey, or 250 mL beer)
• • Known hypersensitivity to any component of the investigational product.
• * Clinically significant renal, hepatic, cardiovascular, respiratory, metabolic, or infectious diseases, including but not limited to:
• • Moderate to severe renal impairment (eGFR or creatinine clearance \<45 mL/min)
• • Dialysis
• • Acute or unstable heart failure
• • Acute myocardial infarction, septicemia, or shock
• • Type 1 diabetes, metabolic acidosis, or history of diabetic ketoacidosis
• • Major surgery planned during the study (except minor procedures not affecting food or fluid intake)
• • Severe infections, trauma, or nutritional deficiencies
• • Positive pregnancy test or currently breastfeeding (for female subjects).
• • History of significant psychiatric illness.
• • Determined by the investigator to be unsuitable for the study for any other reason.