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The primary objective is to evaluate the effect of omeprazole on the pharmacokinetics of famitinib malate in healthy adult subjects.
The secondary objective is to evaluate the safety after famitinib malate alone or combined administration with omeprazole in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | The study will have only one study group in a fixed-sequence type of design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| famitinib、omeprazole | Drug | famitinib malate, 25 mg on study day 1; omeprazole, 40 mg, qd on study day 10-14, 16-22; famotine malate together with omeprazole, on study day 15. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | day 1 to day 23 | |
| AUC0-t | day 1 to day 23 | |
| AUC0-∞(if applicable) | day 1 to day 23 | |
| Tmax | day 1 to day 23 | |
| t1/2 | day 1 to day 23 | |
| CL/F | day 1 to day 23 | |
| Vz/F | day 1 to day 23 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events/serious adverse events | from ICF signing date to approximate day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, Affiliated to Southest University | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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This is a single-arm, open-label and fixed-sequence drug interaction study.
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