Pharmacokinetics and Relative Bioavailability of Carvedilol Tablets in Healthy Volunteers

The Pharmacokinetics and relative bioavailability of domestic and importedcarvedilol tablets were studied following a single oral dose of 20mg given to 10 normalmale volunteers in a randomized crossover design. Plasma levels were determined by HPLC-fluorescence. The time course of plasma concentration of careedilol tablets after oral dosingwas fitted to the two compartment model. The main pharmacokinetic parameters were Cmax72.5±27.3 and 71.4± 27.9 μg·L-1 at 1.15±0.88 and 1.15± 0.78 h, T1/2β7.57±2.61and 7.74±3.22 h, AUCo-t,281 .8±62.2 and 308.6±114.4 μg·L-1·h, AUC0~∞ 314.9±67.1 and 345.8±127.9 μg·-1·h for domestic and imported tablets, respectively.The relative bioavailability of domestic tablets was 98.5±24.6%. The bioequivalence ofthe two tablets were calculated by analysis of variance, two one-sidedt tests and 90%-confidence intervals. The results of statistical analysis demonstrated that the two tabletswere bioequivalent.