盐酸特比萘芬片在中国健康受试者体内的生物等效性研究

目的 研究盐酸特比萘芬片在中国健康受试者中的药代动力学,评价国产受试制剂与原研参比制剂的生物等效性.方法 采用空腹/餐后、随机、开放、单剂量、两周期、两序列、双交叉试验设计.空腹试验和餐后试验各入组36例健康受试者,随机分为2组,每周期单次空腹或餐后口服盐酸特比萘芬片受试制剂或参比制剂125 mg.用液相色谱-串联质谱...

Bioequivalence of terbinafine hydrochloride tablets in healthy subjects in China

Objective To study the pharmacokinetics of terbinafine hydrochloride tablets in healthy subjects in China,and to evaluate the bioequivalence between the domestic test preparation and the original reference preparation.Methods A fasting and fed,random,open,single-dose,two-period,two sequences,crossover drug trial design was adopted.Thirty-six subjects were randomly divided into two groups,and administered oral test(T)or reference(R)terbinafine hydrochloride tablets 125 mg each period under fasting and fed condition respectively.The concentrations of terbinafine in plasma at different time points were determined by LC-MS/MS.The pharmacokinetic parameters were calculated and the bioequivalence was compared by Phoenix WinNonlin6.4 program.Results The pharmacokinetic parameters of terbinafine for test and reference preparations in fasting condition were as follows:Cmax were(626±258)and(666±313)ng·mL^-1;AUC0-t were(2400±985)and(2560±1070)ng·h·mL^-1;AUC0-∞were(2630±1110)and(2790±1180)ng·h·mL^-1 respectively.The pharmacokinetic parameters of terbinafine for test and reference preparations in fed condition were as follows:Cmaxwere(741±290)and(716±274)ng·mL^-1;AUC0-t were(4000±1130)and(4120±1220)ng·h·mL^-1;AUC0-∞were(4480±1280)and(4670±1670)ng·h·mL^-1 respectively.The 90%confidence intervals of the geometric mean ratios of Cmax,AUC0-t,AUC0-∞for the test preparation and the reference preparation were all between 85.24%and 116.03%.Conclusion The test and reference preparations of terbinafine tablets were bioequivalent in healthy Chinese subjects under fasting and fed conditions.