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

Purpose: The purpose of this study was to examine the pharmacokinetics (PK), bioequivalence and safety of generic sunitinib and its original product Sutent (R) 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 (R) 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 C-max, AUC(0-t) and AUC(0-infinity) 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 (R). These results advocate the clinical application of generic sunitinib as a potential alternative to original product Sutent (R) in the treatment of certain medical conditions.

Automated summary

This study investigated the pharmacokinetics, bioequivalence, and safety of generic sunitinib and its original product Sutent (R) in healthy Chinese subjects through a phase-I clinical trial. The results demonstrated that the two drugs had comparable pharmacokinetics and were bioequivalent. Both drugs also exhibited good safety profiles.