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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04859439 | A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Renal Impairment | PHASE1 | COMPLETED | 40 | — | — | Jun 15, 2021 | Dec 31, 2021 | May 10, 2022 | 1 | China |
Cmax
Ae
| Arm | Type | Description |
|---|---|---|
| Mild Renal Impairment | EXPERIMENTAL | Subjects will receive a single dose of 100 mg DBPR108 |
| Moderate Renal Impairment | EXPERIMENTAL | Subjects will receive a single dose of 100 mg DBPR108 |
| Severe Renal function | EXPERIMENTAL | Subjects will receive a single dose of 100 mg DBPR108 |
| Kidney failure | EXPERIMENTAL | Subjects will receive a single dose of 100 mg DBPR108 |
| Normal Renal function | EXPERIMENTAL | Subjects will receive a single dose of 100 mg DBPR108 |
| Name | Type | Description |
|---|---|---|
| DBPR108 tablets | DRUG | Drug: DBPR108, tablet, oral |
Inclusion Criteria: All subjects: * Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions； * 18 years to 79 years (inclusive), male and female； * Male subjects weight ≥50 kg and female subjects weight ≥45 kg...