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 is a single-center, single-dose, randomized, open-label, parallel sstudy to evaluate the relative bioavailability of new and old formulations of SHR3680 tablets in healthy male subjects under fasting conditions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Test formulation of SHR3680 |
|
| Reference group | Other | Reference formulation of SHR3680. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| test SHR3680 tablets | Drug | Subjects receiving a single oral dose of SHR3680 tablets with 240mg (80mg*3) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fr | Fr=AUC (test formulation)/AUC (reference formulation) | predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing |
| Cmax | predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing | |
| AUC0-t | predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing | |
| AUC0-∞ | predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing | |
| T1/2 | predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Guanzhou | Guangdong | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| reference SHR3680 tablets | Drug | subjects receiving a single oral dose of SHR3680 tablets with 240mg (100mg*2+20mg*2). |
|
| Vd |
| predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing |
| CL/F | predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 168 and 336 hour after dosing |
| The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0) | From the screening to the scheduled last visit day (Day 49±1 after dosing) |