Bioequivalence of Domestic and Imported Phenazopyridine Hydrochloride Tablets in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study pharmacokinetics of domestic and imported Phenazopyridine hydrochloride tables and bioavailability of domestic tablets, and to evaluate the bioequivalence of two kinds of tablets. METHODS: A randomized crossover design was performed in 18 healthy male volunteers. They received a single oral dose of domestic or imported tablets 200 mg. Plasma concentration of phenazopyridine hydrochloride was measured by HPLC. The pharmacokinetic parameters were calculated by 3p97 software and relative bioavailability was evaluated. RESULTS: The plasma concentration-time curves of domestic and imported tablets conformed to one-compartment model. Main pharmacokinetic parameters of domestic tablets vs. imported tablets were as follows: t1/2Ke(3.52?2.03) h vs. (3.18?1.85)h; tmax(0.76?0.33) h vs. (0.79?0.43)h; Cmax(76.41?70.15) ng?mL-1 vs. (75.49?70.37) ng?mL-1; AUC0～8(159.10?116.32) ng?h?mL-1 vs. (164.65?129.89) ng?h?mL-1; AUC0～∞(237.12?115.06) ng?h?mL-1 vs. (262.69?155.05) ng?h?mL-1. The relative bioavailability of domestic tablets was (96.63?14.05)% compared with imported tablet. There was no significant difference between the pharmacokinetic parameters of two formulations by variance analysis, t-test and 1-2? confidence interval method. CONCLUSION: The domestic and imported tablets are bioequivalent.