To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults after taking the drugs with food (fed state).
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.
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).
Crossover
Comparator 1
DrugDapagliflozin 10mg + Linagliptin 5mg
Comparator 2
DrugMetformin 1000mg
Test Drug
DrugFixed-dose combination tablet (AJU-A53)
Cmax of Metformin
To assess the maximum observed plasma concentration (Cmax) of Metformin
AUCt of Metformin
To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Metformin
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This trial is not recruiting at the moment. You can still explore other options:
