Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a single-center, open-label, crossover study, conducted in healthy Chinese populations, and plans to enroll 48 healthy adult subjects (male and female).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental | Period 1: HSK16149 single dose on D1, 40mg, fasted; Period 2: HSK16149 single dose on D2, 40mg, fasted; Probenecid QID (500mg) on D1~D4. HSK16149 would be administered 2 hours after the first dose of probenecid on D2. |
|
| A2 | Experimental | Period 1: HSK16149 single dose on D2, 40mg, fastedï¼›probenecid QID (500mg) on D1~D4. HSK16149 would be administered 2 hours after the first dose of Probenecid on D2. Period 2: HSK16149 single dose on D1, 40mg, fasted; |
|
| B1 | Experimental | Period 1: HSK16149 single dose on D1, 40mg, fasted; Period 2: HSK16149 single dose on D2, 40mg, fasted; Cimetidine QID (200mg) on D1~D4. HSK16149 would be administered 1 hour after the first dose of Cimetidine on D2. |
|
| B2 | Experimental | Period 1: HSK16149 single dose on D2, 40mg, fasted; Cimetidine QID (200mg) on D1~D4. HSK16149 would be administered 1 hour after the first dose of Cimetidine on D2. Period 2: HSK16149 single dose on D1, 40mg, fasted; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK16149,probenecid, cimetidine | Drug | 40mg HSK16149 single dose, fasted; 500mg probenecid QID from D1~D4 200mg cimetidine QID from D1~D4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The maximun plasma concentration of HSK16149 | From the start to 72 hours after administration |
| AUC0-t | Area under the concentration-time curve from time zero to time of last quantifiable concentration | From the start to 72 hours after administration |
| AUC0-inf | Area under the concentration-time curve from time zero extrapolated to infinite time | From the start to 72 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time of maximum concentration | From the start to 72 hours after administration |
| t1/2 | half life | From the start to 72 hours after administration |
Not provided
Inclusion Criteria:
7. Subjects (including partners) are willing to voluntarily use effective contraceptives from screening to at least 6 months after the last dose administration.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Jishuitan Hoispital | Beijing | China |
Not provided
| ID | Term |
|---|---|
| D002927 | Cimetidine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vz | Volume of distribution associated with the terminal phase | From the start to 72 hours after administration |
| CL | Plasma clearance | From the start to 72 hours after administration |
| Ae | Cumulative urinary recovery of unchanged drug | From the start to 72 hours after administration |
| Fe | Cumulative urinary recovery fraction of unchanged drug | From the start to 72 hours after administration |
| CLr | Renal clearance | From the start to 72 hours after administration |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |