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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06226727 | A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-1" and "BR1019-2" | PHASE1 | COMPLETED | 52 | — | — | Feb 14, 2024 | Mar 31, 2024 | Apr 2, 2024 | 1 | South Korea |
Area under the concentration-time curve from time zero to time τ
Maximum concentration of drug in plasma
| Arm | Type | Description |
|---|---|---|
| Sequence Group A | EXPERIMENTAL | The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1\~4. \*Sequence Group A \[Period 1, 3\] Co-administration of BR1019-1(R1) and BR1019-2(R2). \[Period 2, 4\] Administration of BR1019(T) |
| Sequence Group B | EXPERIMENTAL | The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1\~4. \*Sequence Group B \[Period 1, 3\] Administration of BR1019(T) \[Period 2, 4\] Co-administration of BR1019-1(R1) and BR1019-2(R2). |
| Name | Type | Description |
|---|---|---|
| BR1019 | DRUG | One tablet administered alone |
| BR1019-1 | DRUG | One tablet administered alone |
| BR1019-2 | DRUG | One tablet administered alone |
Inclusion Criteria: * Those who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit * In case of a male subject, Those who weigh 50 kg or more * In case of a female subject, Those who weigh 45 kg or more * Those who decide to voluntarily participate after listen...