Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07034781 | A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults | PHASE1 | NOT YET_RECRUITING | 50 | — | — | Aug 1, 2025 | Nov 1, 2025 | Jun 24, 2025 | 1 | South Korea |
To assess the maximum observed plasma concentration (Cmax) of Dapagliflozin
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Dapagliflozin
To assess the maximum observed plasma concentration (Cmax) of Linagliptin
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Linagliptin
To assess the maximum observed plasma concentration (Cmax) of Metformin
To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Metformin
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Two-period, single-dose, crossover study |
| Group B | EXPERIMENTAL | Two-period, single-dose, crossover study (reversed order) |
| Name | Type | Description |
|---|---|---|
| Comparator 1 | DRUG | Dapagliflozin 10mg + Linagliptin 5mg |
| Comparator 2 | DRUG | Metformin 1000mg |
| Test Drug | DRUG | Fixed-dose combination tablet (AJU-A53) |
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 requir...