Type2 Diabetes Mellitus
Conditions
Brief summary
To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults
Interventions
DRUGComparator 1
Dapagliflozin 10mg + Linagliptin 5mg
DRUGComparator 2
Metformin 1000mg
DRUGTest Drug
Fixed-dose combination tablet (AJU-A53)
Sponsors
AJU Pharm Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt of Linagliptin | 0 hour ~ 72 hour after drug administration | To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Linagliptin |
| Cmax of Metformin | 0 hour ~ 48 hour after drug administration | To assess the maximum observed plasma concentration (Cmax) of Metformin |
| Cmax of Dapagliflozin | 0 hour ~ 48 hour after drug administration | To assess the maximum observed plasma concentration (Cmax) of Dapagliflozin |
| AUCt of Dapagliflozin | 0 hour ~ 48 hour after drug administration | To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Dapagliflozin |
| Cmax of Linagliptin | 0 hour ~ 72 hour after drug administration | To assess the maximum observed plasma concentration (Cmax) of Linagliptin |
| AUCt of Metformin | 0 hour ~ 48 hour after drug administration | To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Metformin |
Countries
South Korea
Outcome results
None listed