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目的:评价2种罗格列酮钠片在健康人体内的生物等效性。方法:20名健康男性志愿者采用双周期随机交叉设计自身对照法,单剂量口服2种罗格列酮钠片剂(受试制剂和参比制剂)8mg,用反相高效液相色谱-荧光法测定罗格列酮钠的血药浓度。结果:受试制剂与参比制剂的主要药动学参数:Tmax分别为(2.00±0.00)和(2.16±1.27)h;Cmax分别为(743.54±173.23)和(707.68±77.62)ng·mL-1;t1/2分别为(3.70±0.63)和(3.46±2.18)h;AUC0～24分别为(2811.46±151.23)和(2473.04±75.07)ng·h·mL-1;AUC0～∞分别为(2947.53±164.77)和(2489.19±99.25)ng·h·mL-1;受试制剂相对生物利用度为(105.97±18.82)%。经方差分析和双单侧t检验结果显示,2种片剂具有生物等效性。结论:2种罗格列酮钠片具有生物等效性。
Objective: To evaluate the bioequivalence of two rosiglitazone sodium tablets in healthy volunteers. Methods: Twenty healthy male volunteers were randomized, double-cycle crossover design, to self-control. A single oral dose of 8 mg sodium rosiglitazone tablets (test and reference preparations) was administered orally, using reversed-phase high performance liquid chromatography Determination of plasma concentration of rosiglitazone sodium. Results: The main pharmacokinetic parameters of test preparation and reference preparation were: Tmax (2.00 ± 0.00) and (2.16 ± 1.27) h respectively; Cmax were (743.54 ± 173.23) and (707.68 ± 77.62) ng · mL- 1; t1 / 2 were (3.70 ± 0.63) and (3.46 ± 2.18) h respectively; AUC0-24 were (2811.46 ± 151.23) and (2473.04 ± 75.07) ng · h · mL- 2947.53 ± 164.77) and (2489.19 ± 99.25) ng · h · mL-1 respectively. The relative bioavailability of the test preparation was (105.97 ± 18.82)%. Analysis of variance and double-sided t-test showed that the two tablets were bioequivalent. Conclusion: Two rosiglitazone sodium tablets are bioequivalent.