Pharmacokinetics and relative bioavailability of compound paracetamol tablet in healthy volunteers

Objective To study the pharmacokinetics and relative bioavailability of compound paracetamol tablet(Ⅱ) in healthy volunteers . Methods In a randomized two-period cross-over study, a single oral dose of two tablets(test and reference ) were given to 24 healthy volunteers.The plasma concentrations of paracetamol,propyphenazone and caffeine were determined by HPLC method. The pharmacokinetic parameters of the two preparations and the relative bioavailability of paracetamol,propyphenazone and caffeine were calculated with statistical analysis. Results The main pharmacokinetic parameters of paracetamol were as follow :t_ max were (0.81±0.48)and(0.78±0.30) h,C_ max were (9.29± 2.23 ) and (8.76±1.83) μg·mL~ -1 ,AUC_ 0-24 were (31.49±6.83) and (31.64±7.77) μg·h·mL~ -1 for test and reference respectively. Pharmacokinetic parameters of propyphenazone were as follow :t_ max were ( 0.90 ±0.33) and (0.88±0.30) h,C_ max were (6.99±1.79)and( 7.00 ±1.60) μg·mL~ -1 ,AUC_ 0-24 were (21.92±9.43)and(19.51±5.22) μg·h·mL~ -1 for test and reference respectively. The relative bioavailability of paracetamol were (102.3±22.4)%, and(112.8± 37.4 )% for propyphenazone.Conclusion The two preparations were bioequivalent.FL)