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

Launched by AJU PHARM CO., LTD. · Jun 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and how the body processes three medicines—dapagliflozin, linagliptin, and metformin—that are often used to treat type 2 diabetes. The study will be done with healthy adults to better understand how these drugs behave in the body and to make sure they are safe when taken together.

People who might join this study are healthy men or women between 19 and 50 years old, with a body weight and body mass index (BMI) in a certain range, and who don’t have any serious health issues. Participants will be carefully checked through medical history, physical exams, and lab tests before joining. If you take part, you’ll be asked to avoid certain medications and substances, and women will need to use non-hormonal birth control during the study and for a while after. The study is not yet open for enrollment, and if you qualify, you can expect close medical monitoring to ensure your safety throughout the trial.

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 50 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.