Study on Bioequivalence of Compound Fluamine Tablets in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To evaluate the bioequivalence of compound fluamine tablets with commercial fluamine tablets and glibenclamide tablets(R).METHODS:HPLC method was used to determine the plasma drug time-concentrations of flu?amine and glibenclamide separately.The pharmacokinetic parameters were calculated and analysed with variance and two-one side t-test.RESULTS:The T 1/2 ,T max ,C max and AUC 0～24 for fluamine of test and reference formulation were(7.969?0.713)h and(8.103?0.596)h;(1.889?0.214)h and(1.876?0.207)h;(2.001?0.368)?g/ml and(1.962?0.416)?g/ml;(10.706?1.424)(?g?h)/ml and(10.624?1.317)(?g?h)/ml respectively.F was(100.97?7.73)%.The T 1/2 ,T max ,and AUC 0～24 for glibenclamide of test and reference formulation were(6.536?0.890)h and(6.629?0.563)h;(4.038?0.309)h and(4.056?0.338)h;(98.026?22.790)ng/ml and(97.507?20.529)ng/ml;(510.702?135.818)(ng?h)/ml and(499.452?111.328)(ng?h)/ml,respectively,and F was(102.066?12.405)%.CONCLUSION:The statistical analysis showed that com?pound fluamine tablets and commercial fluamine tablets and glibenclamide tablets were bioequivalent.