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
Not provided
The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of SHR2554 Tablets in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2554 | Drug | On an empty stomach - after meals |
| |
| SHR2554 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of SHR2554: Cmax | day 1 to day 10 | |
| Pharmacokinetic parameters of SHR2554: AUC0-t | day 1 to day 10 | |
| Pharmacokinetic parameters of SHR2554: AUC0-∞ (if applicable) | day 1 to day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of SHR2554: Tmax | day 1 to day 10 | |
| Pharmacokinetic parameters of SHR2554: t1/2 | day 1 to day 10 | |
| Pharmacokinetic parameters of SHR2554: CL/F |
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 |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Randomized, open-label, single-dose, two-cycle, two-sequence, cross-controlled
Not provided
Not provided
Not provided
Not provided
| Drug |
After meals - on an empty stomach |
|
| day 1 to day 10 |
| Pharmacokinetic parameters of SHR2554: Vz/F | day 1 to day 10 |
| The incidence and severity of adverse events/serious adverse events. | from ICF signing date to approximate day 17 |