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To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults after taking the drugs with food (fed state).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Two-period, single-dose, crossover study |
|
| Group B | Experimental | Two-period, single-dose, crossover study (reversed order) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator 1 | Drug | Dapagliflozin 10mg + Linagliptin 5mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Metformin | To assess the maximum observed plasma concentration (Cmax) of Metformin | 0 hour ~ 48 hour after drug administration |
| AUCt of Metformin | To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Metformin | 0 hour ~ 48 hour after drug administration |
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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.
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:
Known hypersensitivity to any component of the investigational product.
Clinically significant renal, hepatic, cardiovascular, respiratory, metabolic, or infectious diseases, including but not limited to:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Gwangmyeong Hospital | Gwangmyeong | Gyeonggi-do | South Korea |
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| Comparator 2 |
| Drug |
Metformin 1000mg |
|
| Test Drug | Drug | Fixed-dose combination tablet (AJU-A53) |
|
| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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