Pharmacokinetics properties and bioequiavailability of nifedipine sustained-release tablets after multiple doses administration in healthy volunteers
AIM: To investigate the pharmacokinetics properties and bioequiavailability of nifedipine sustained-releane tablets after multiple doses administration in healthy volunteers. METHODS: An open, randomized and two-period crossover study with a 2-week washout interval wan performed in 20 healthy volunteers. Concentrations of nifedipine in plasma were assayed by LC-MS/MS spectrometric method after multiple doses of 20 nag of the tested or the referenced tablets. The pharmacokinetics parameters, T_(max)T, C_(max), T1/2 and AUCss were analyzed by two one-side t test and (1 -2 a )90%. RESULTS: The main pharmacokinetics of the tested and referenced tablets were: T_(max) : (4.10 ± 1.07 ) and (4.55±1.23) h; C_(max): (52.64±15.80) and (51.54±12.87)ng/mL; T1/2 (8.44±1.69) and (8.33±2.27) h; and AUCss:(352.96±85.12) and (367.96±71.28) ng/(h · mL). The relative bioavailiability of nifedipine was (96. 2 ± 17. 3 )%.CONCLUSION: The results of the statistical analysis shows that the two formulations are bioequivalent.
NETL
NSTL
万方数据
维普
