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目的:研究依诺沙星分散片(受试制剂)和依诺沙星片(参比制剂)的生物等效性。方法:采用双周期随机交叉试验设计。分别予20名男性健康志愿者依诺沙星受试制剂或参比制剂各0.4 g单剂量口服。用HPLC法测定给药后血样中依诺沙星的浓度。用DAS软件计算药动学参数。结果:受试制剂与参比制剂的Cm ax分别为(5 320±1 275)和(5 163±1 241)ng.mL-1;Tm ax(0.88±0.37)和(0.89±0.37)h;AUC0→24 h(23 317±7 187)和(22 904±7 098)ng.h.mL-1;AUC0→∞(24 502±7 396)和(24 085±7 377)ng.h.mL-1。受试制剂的相对生物利用度为(102±9)%。结论:依诺沙星分散片与依诺沙星片生物等效。
OBJECTIVE: To study the bioequivalence of enoxacin dispersible tablets (test preparations) and enoxacin tablets (reference preparations). Methods: Double-cycle randomized crossover design. 20 male healthy volunteers enoxacin test preparations or reference preparations of 0.4 g each single oral dose. The concentration of enrofloxacin in blood samples after administration was determined by HPLC method. Pharmacokinetic parameters were calculated using DAS software. Results: Cm ax was (5 320 ± 1 275) and (5 163 ± 1 241) ng.mL-1 respectively; Tm ax (0.88 ± 0.37) and (0.89 ± 0.37) h, AUC0 → 24 h (23 317 ± 7 187) and (22 904 ± 7 098) ng.h.mL-1; AUC0 → ∞ (24 502 ± 7 396) and (24 085 ± 7 377) ng.h.mL -1. The relative bioavailability of the test preparation was (102 ± 9)%. Conclusion: Enoxacin dispersible tablets are bioequivalent to Enoxacin tablets.