Bioequivalence of two kinds of suitamicillin tablets in healthy human volunteers

AIM:To study the phamacokinetics and correlative bioavailability and evaluate the bioequiva- lence of two kinds of sultamicillin tablets.METHODS:A random crossover trial was designed.Plasma concen- trations were determined by HPLC method following a single oral dose 750 mg of two different brands suhami- cillin tablets.RESULTS:The ampicillin pharmacokinetic parameters of the test tablets and the reference tablets in plasma were as following: t_(max) were(l.1±s 0.3)vs(1.2±0.4)h;c_(max) were(10±5)vs(11±6)mg·L~(-1);t_(1/2) were(1.8±0.5)vs(1.6±0.4)h;AUC_(0-8) were(22±15)vs(22±15)mg·h·L~(-1),respectively.The ampicillin bioavailability of the test tablets was(100±10)% in correlative with the reference tablets.The sulbactam phar- macokinetic parameters of the test tablets and the reference tablets in plasma were as following:t_(max) were(1.2±0.3)vs(1.3±0.4)h;c_(max) were(5.5±1.2)vs(5.6±1.1)mg·L~(-1);t_(1/2) were(1.5±0.3)vs(1.46±0.28)h; A UC_(0-8) were(10.6±2.1)vs(10.2±1.6)mg·h·L~(-1),respectively.The sulbactam bioavailability of the test tablets was(102±11)% in correlative with the reference tablets.CONCLUSION:The two kinds of sultamicillin tablets are bioequivalent.