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The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib and 14C-labeled Anlotinib | Experimental | each participant will be given a single dose of 14C-labeled gilteritinib. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib and 14C-labeled Anlotinib | Drug | oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative excretion of 14C-labeled Anlotinib (radioactivity in urine) | up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%) | |
| Cumulative excretion of 14C-labeled Anlotinib (radioactivity in feces) | up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%) | |
| Excretion rate of 14C-labeled Anlotinib (radioactivity in urine) | up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%) | |
| Excretion rate of 14C-labeled Anlotinib (radioactivity in feces) | up to 10 Days (endpoint when the two consecutive time points of cumulative excretion <1%) | |
| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Peak Plasma Concentration(Cmax) | Peak Plasma Concentration(Cmax),Cmax in ng/mL, | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Peak time（Tmax） | Peak time（Tmax）,Tmax in h. | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Half life（t1/2） | Half life（t1/2）,t1/2 in h. | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolite identification of Anlotinib in plasma, urine and feces | up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lihua Bao, Doctor | The First Affiliated Hospital with Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood): Area under the plasma concentration versus time curve (AUC) | Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL. | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood): Clearance（CL） | Clearance（CL）,CL in L/h. | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |