Pharmacokinetics and bioequivalence of two pantoprazole sodium enteric-coated tablet products in healthy Chinese volunteers

摘要

Aim To evaluate the pharmacokinetics and bioequivalence of domestic pantoprazole sodium enteric-coated tablets as compared with imported pantoprazole enteric-coated tablets. Methods This was an open randomized, two periods cross over study on twenty healthy male volunteers. The pantoprazole concentrations in plasma after an oral dose of 40 mg pantoprzaole preparations were determined by a HPLC-UV method. Non-compartmental method was used for the calculation of pharmaco-kinetic parameters. Logarithm-transformed C_(max) and AUC were analyzed by the analysis of variance (ANOVA) with 90% confidence intervals. Results The main pharmacokinetics parameters of domestic pantoprazole sodium enteric-coated tablets and imported pantoprazole sodium enteric-coated tablets were as following: C_(max) (3610 ± 956), (3466 ± 1209) ng·mL~(-1), t_(max) (3.00 ± 0.40), (3.00 ± 0.46) h, A UC_(0-T), (8140 ± 5065), (8390 ± 5474) nghmL~(-1), AUC_(0-∞) (8293 ± 5094), (8625 ± 5606) ng·h·mL~(-1), t_(1/2) (1.61 ± 0.28), (1.85 ± 0.27) h, respectively. Conclusion Domestic pantoprazole sodium enteric-coated tablets were bioequivalent with the imported pantoprazole sodium enteric-coated tablets.