Pharmacokinetics and relative bioavailability of seratrodast granules in healthy volunteers

Objective To study the pharmacokinetics and relative bioavailability of seratrodast in 20 healthy volunteers. Methods A single oral dose 80mg seratrodast of reference or test drugs was given to each volunteer according to an open randomized crossover study. The concentrations in plasma were determined by RP-HPLC method using liquid-liquid extraction methods. Results The main pharmacokinetic parameters of seratrodast were as follows: AUC0-96 were 54.99 ±5.97 and 55.04 ± 6.75 h-mg.L-1; Cmax were 2.63 ± 1.04 and 2.73± 0.96 mg-L-1, tmax were 3.35±0.49 and 3.20 ± 0.89 h; t1/2 were 22.47 ±4.96 and 22.66±3.47 h for test and reference drug, respectively. The relative bioavailability were(101.1±14.4)%, (100.2±13.1)%, respectively. Conclusion The result of statistical analysis showed that two formulations were bioequivalent.