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Table 3 Pharmacokinetic parameters of anlotinib after a single oral dose of anlotinib capsules in cancer patients and summarized results from dose proportionality assessment

From: Safety, pharmacokinetics, and antitumor properties of anlotinib, an oral multi-target tyrosine kinase inhibitor, in patients with advanced refractory solid tumors

Pharmacokinetic parameters Measurement of dose-dependent pharmacokinetics Assessment of dose proportionality
5 mg/person (n = 1) 10 mg/person (n = 4) 12 mg/person (n = 11) 16 mg/person (n = 4) r P Slope (90 % CI) Conclusion
C max, ng/mL 5.8 5.8 ± 2.8 10.5 ± 2.9 15.8 ± 3.2 0.629 0.003 1.12 (0.54–1.71) Inconclusive
T max, h 11.0 6.0 ± 4.4 7.3 ± 3.3 11.0 ± 8.9
AUC0–120h, h·ng/mL 411 318 ± 133 617 ± 194 894 ± 305 0.465 0.045 0.81 (0.16–1.45) Inconclusive
AUC0–∞, h·ng/mL 687 562 ± 328 1066 ± 263 1585 ± 470 0.666 0.002 1.18 (0.62–1.73) Inconclusive
t 1/2, h 102 95 ± 22 116 ± 47 98 ± 15
  1. Critical intervals were 0.791–1.209 for the systemic exposure data of anlotinib from a single oral dose of anlotinib capsules (10–16 mg) in cancer patients. The term r denotes the correlation coefficient. Correlations were statistically significant with P < 0.05. The term “linear” was concluded statistically if the 90 % confidence interval (90 % CI) for the slope was contained completely within the critical interval; inconclusive was concluded statistically if the 90 % CI lies partly within the critical interval; nonlinear was concluded statistically if the 90 % CI was entirely outside the critical interval
  2. C max maximum plasma concentration, T max the time taken to achieve the maximum plasma concentration, AUC 0–120h the area under concentration-time curve up to 120 h, AUC 0–∞ area under concentration-time curve up to infinity, t 1/2 terminal elimination half-life