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he primary purpose of this study is to investigate potential pharmacokinetic interaction in healthy volunteers when apatinib is administered in combination with itraconazole. Secondary objective is evaluating the safety and tolerability of apatinib alone and when co-administered with itraconazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | subjects receiving a single 250 mg oral dose of apatinib mesylate tablets and wash-out for 3 days,then Itraconazole capsules 100 mg/day orally for 6 days with a single 250 mg oral dose of apatinib mesylate tablets co-administered on day 4 . apatinib mesylate tablets was administered in the morning after an overnight fast of at least 10 h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib Mesylate Tablets | Drug | apatinib was administered in the morning after an overnight fast of at least 10 h |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of Apatinib | 0~72h after apatinib administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From first administration to the seventh day after last administration | |
| Peak Plasma Concentration (Cmax) of Apatinib | 0~72h after apatinib administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen Yu | Shanghai Xuhui Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole Capsules | Drug | rifampicin was administered in the morning 0.5 hours after breakfast |
|
|
| D010879 |
| Piperazines |