A randomized, open, two-period, two-sequence crossover trial design used to assess the pharmacokinetics and safety of Sunitinib Malate Capsules in healthy volunteers under fed condition, and compare the bioequivalence of Sunitinib Malate Capsules produced by Pfizer and Chia Tai Tianqing Pharmaceutical Group Co., Ltd, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).
Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, China
Maximum plasma concentration (Cmax)
Maximum plasma concentration
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Time to maximum concentration (Tmax)
Time to reach maximum concentration after drug administration
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Area under the drug-time curve (AUC)
Area under the drug-time curve
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Apparent terminal elimination half-life (t1/2)
Apparent terminal elimination half-life (t1/2)
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Apparent volume of distribution (Vd/F)
Apparent volume of distribution
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Clearance rate (CL/F)
Clearance rate
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Apparent terminal elimination rate constant (λz)
Apparent terminal elimination rate constant
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Relative bioavailability (F)
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Relative bioavailability (F) of the tested product to reference product
Time frame: Before administration and 2, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96, 120, 168 hours after administration.
Incidence of adverse events (AE)
Incidence of adverse events (AE) evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) V5.0.
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Severity of adverse events (AE)
Severity of adverse events (AE) evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal blood biochemistry results
The proportion of subjects with abnormal blood biochemistry results evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal blood routine
The proportion of subjects with abnormal blood routine results evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal urinalysis results
The proportion of subjects with abnormal urinalysis results evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal coagulation function
The proportion of subjects with abnormal coagulation function evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal thyroid function
The proportion of subjects with abnormal thyroid function evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal blood pressure
The proportion of subjects with abnormal blood pressure evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal pulse
The proportion of subjects with abnormal pulse evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal body temperature
The proportion of subjects with abnormal body temperature evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.
Proportion of subjects with abnormal 12-lead electrocardiogram (ECG)
The proportion of subjects with abnormal 12-lead ECG evaluated in accordance with the National Cancer Institute's Common Toxicity Criteria (NCI CTC) v5.0.
Time frame: From the date of randomization until the date of withdrawal from the study for any reason. Assessed up to 40 days.