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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07049107 | Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects | PHASE1 | COMPLETED | 14 | — | — | Jun 23, 2025 | Jul 21, 2025 | Mar 16, 2026 | 1 | China |
Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Observed maximum plasma concentration. Blood samples will be collected.
Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Bupropion, hydroxybupropion and midazolam, hydroxymidazolam. Observed time to reach Cmax. Blood samples will be collected.
| Arm | Type | Description |
|---|---|---|
| HRS-8427 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| HRS-8427 | DRUG | HRS-8427 |
Inclusion Criteria: 1. Healthy subjects aged 18 to 45 years old (including 18 and 45 years old, based on the time of signing the informed consent form), both male and female. 2. The weight of female subjects was ≥45 kg, the weight of male subjects was ≥50 kg, and the body mass index (BMI) was withi...