Pharmacokinetics and relative bioavailability of seratrodast granule in healthy volunteers

Aim To study the pharmacokinetics and relative bioavailability of seratrodast granule in 20 healthy volunteers.Methods A single oral dose 100 mg seratrodast of test formulation or 80 mg reference formulation was given to each volunteer according to an open randomized crossover study.The concentrations in plasma were determined by RP-HPLC method.Results The main pharmacokinetic parameters of seratrodast were as follows:t1/2ke were(21.71±4.10)h and(21.50±5.64)h,tmax were(4.1±1.3)h and(4.5±1.6)h,Cmax were(4.82±0.87)mg·L-1 and(4.13±0.78)mg·L-1,AUC0-96 were(115.28±27.49)mg·h-1·L-1 and(92.68±17.68)mg·h-1·L-1 for test and reference formulations respectively.The relative Bioavailability of AUC0-96 was 100.55%±19.67%.Conclusion The results of statistical analysis showed that two formulations were bioequivalent.