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Pharmacokinetics and bioequivalence of sunitinib and Sutent® in Chinese healthy subjects: an open-label, randomized, crossover study.


ABSTRACT: Purpose: The purpose of this study was to examine the pharmacokinetics (PK), bioequivalence and safety of generic sunitinib and its original product Sutent® in healthy Chinese subjects through a phase-I clinical trial. Methods: The study selected two groups of 24 healthy Chinese subjects in a 1:1 ratio through random allocation. Each participant received either 12.5 mg of sunitinib or Sutent® per cycle. A total of 15 different time points were employed for blood sample collection during each cycle. Furthermore, a comprehensive assessment of the drugs' safety was consistently maintained throughout the trial. Results: The average adjusted geometric mean ratios (GMR) (90% CI) for the primary PK parameters Cmax, AUC0-t and AUC0-∞ were 97.04% (93.06%-101.19%), 98.45% (93.27%-103.91%) and 98.22% (93.15%-103.56%), respectively. The adjusted GMRs for essential pharmacokinetic (PK) parameters all met the requirements for bioequivalence, with values within the acceptable range of 80%-125%. In addition, the two drugs showed comparable results for the other PK parameters. These results indicate that the two drugs were bioequivalent. Furthermore, both drugs showed well safety. Conclusion: The research results proved that the PK and safety profiles of sunitinib in healthy Chinese subjects were comparable to those of Sutent®. These results advocate the clinical application of generic sunitinib as a potential alternative to original product Sutent® in the treatment of certain medical conditions.

SUBMITTER: Wang Y 

PROVIDER: S-EPMC10667676 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Pharmacokinetics and bioequivalence of sunitinib and Sutent<sup>®</sup> in Chinese healthy subjects: an open-label, randomized, crossover study.

Wang Yanli Y   Deng Qiaohuan Q   Gao Zhenyue Z   Liu Guangwen G   Su Zhengjie Z   Zhao Yicheng Y   Zhang Lixiu L   Yang Haimiao H  

Frontiers in pharmacology 20231110


<b>Purpose:</b> The purpose of this study was to examine the pharmacokinetics (PK), bioequivalence and safety of generic sunitinib and its original product Sutent<sup>®</sup> in healthy Chinese subjects through a phase-I clinical trial. <b>Methods:</b> The study selected two groups of 24 healthy Chinese subjects in a 1:1 ratio through random allocation. Each participant received either 12.5 mg of sunitinib or Sutent<sup>®</sup> per cycle. A total of 15 different time points were employed for blo  ...[more]

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