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The primary objective of the study was to assess the effect of repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Famitinib.
The secondary objective of the study was to assess the safety of Famitinib given alone versus Famitinib co-administered with Rifampicin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | single dose of Famitinib on Day 1, and co-administered with Rifampicin on Day 16 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famitinib capsule | Drug | single dose and co-administrated with Rifampicin capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Famitinib | Pharmacokinetics parameters of Famitinib | Day 1 to Day 24 |
| AUC0-t of Famitinib | Pharmacokinetics parameters of Famitinib | Day 1 to Day 24 |
| AUCinf of Famitinib | Pharmacokinetics parameters of Famitinib | Day 1 to Day 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of Famitinib | Pharmacokinetics parameters of Famitinib | Day 1 to Day 24 |
| T1/2 of Famitinib | Pharmacokinetics parameters of Famitinib |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266055 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36107220 | Derived | Li T, Li X, Jiang X, Wang C, Sun F, Liu Y, Lin P, Shi P, Fu Y, Gao X, Zhang Y, Cao Y. The effect of rifampin on the pharmacokinetics of famitinib in healthy subjects. Cancer Chemother Pharmacol. 2022 Nov;90(5):409-415. doi: 10.1007/s00280-022-04474-8. Epub 2022 Sep 15. |
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| ID | Term |
|---|---|
| C584390 | famitinib |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Famitinib.
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| Rifampicin capsule | Drug | repeated doses of Rifampicin capsule |
|
|
| Day 1 to Day 24 |
| CL/F of Famitinib | Pharmacokinetics parameters of Famitinib | Day 1 to Day 24 |
| Vz/F of Famitinib | Pharmacokinetics parameters of Famitinib | Day 1 to Day 24 |
| incidence of adverse events/serious adverse events | safety evaluation based on NCI-CTC AE 5.0 | from ICF signing date to approximate Day 31 |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |