The bioequivalence of a single dose of a generic solifenacin succinate tablet or Vesicare in fasting or postprandial healthy Chinese adults.

OBJECTIVE

The present study evaluated the bioequivalence of the test preparation (5 mg generic solifenacin succinate tablet, produced by Jiangsu Deyuan Pharmaceutical Co., Ltd.) or the reference preparation (5 mg solifenacin succinate tablets with the trade name Vesicare, produced by Astellas Pharma Europe B.V.) in either fasting or postprandial states in healthy Chinese subjects.

MATERIALS AND METHODS

The present study was designed as an open-label, randomized, single-center, single-dose, dual-cycle, dual-crossover, fasting/postprandial study. 56 healthy Chinese subjects (28 each in the fasting and postprandial groups) were enrolled. WinNolin software (version 7.0 or above) was used to calculate the pharmacokinetic parameters.

RESULTS

In the fasting and postprandial group, pharmacokinetic analysis and bioequivalence analysis were carried out based on the blood concentration-time data. The 90% confidence interval of the geometric mean ratio of C, AUC, and AUC of the test preparation and the reference preparation were both within the acceptance range of 80.00 - 125.00%.

CONCLUSION

A single administration of a 5-mg tablet of either the test preparation, generic solifenacin succinate, or the reference preparation, solifenacin succinate with the brand-name Vesicare, was safe and bioequivalent in healthy Chinese subjects in either fasting or postprandial states according to the criteria of bioequivalence of the State Drug Administration of China.