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This is a one-arm, fixed-sequence study to compare the pharmacokinetic profiles of SHR6390 in absence and presence of prior administration of proton pump inhibitor Omeprazole. The increased gastric pH achieved by the treatment with multiple doses of Omeprazole might affect the absorption process of SHR6390.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR6390、Omeprazole | Drug | SHR6390 tablet single dose、Omeprazol single dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed serum concentration (Cmax) for SHR6390 after Single dose. | from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose |
| AUC0-t | Area under the plasma concentration versus time curve (AUC0-t) for SHR6390 after Single dose | from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose |
| AUC0-∞ | Area under the plasma concentration versus time curve (AUC0-∞) for SHR6390 after Single dose | from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to maximum observed serum concentration (Tmax) for SHR6390 after Single dose | from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose |
| T1/2 | Time to elimination half-life (T1/2) for SHR6390 after Single dose.[Time Frame](streamdown:incomplete-link) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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The study is a single-center, open, single-dose, Fixed-sequence clinical trial.
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| from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose |
| CL/F | Apparent oral clearance (CL/F) for SHR6390 after Single dose | from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose |
| Vz/F | Apparent Volume of Distribution (Vz/F) SHR6390 after Single dose | from Day1 to Day7after the first dose and from Day17 to Day23 after the second dose |
| Number of subjects with adverse events and severity of adverse events | from Day1 to Day30 after the first dose |