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8名健康男性志愿者,随机交叉口服单剂量(300mg)罗红霉素片剂与胶囊剂.用微生物检定法测定血药浓度.两种制剂的药-时曲线均符合二室模型.达峰时间Tpeak分别为(1.54±0.41)与(1.94±0.44)h;达峰浓度Cmax分别为(6.50±0.30)与(6.50±0.26)u/mL;曲线下面积AUC分别为(121.14±15.91)与(114.62±14.07)(u/mL)·h.两种制剂的药代动力学参数均无显著性差异(P>0.05).罗红霉素片的相对生物利用度为:(105.81±7.06)%.两种制剂生物等效
Eight healthy male volunteers were randomized to receive a single dose (300 mg) of roxithromycin tablets and capsules. Microbiological determination of plasma concentration. The drug-time curves of the two formulations all fit the two-compartment model. The peak time of Tpeak was (1.54 ± 0.41) and (1.94 ± 0.44) h, respectively. The peak concentrations of Cmax were (6.50 ± 0.30) and (6.50 ± 0.30) 26) u / mL; the area under the curve AUC were (121.14 ± 15.91) and (114.62 ± 14.07) (u / mL) · h, respectively. Pharmacokinetic parameters of the two preparations showed no significant difference (P> 0.05). The relative bioavailability of roxithromycin tablets was (105.81 ± 7.06)%. Both formulations are bioequivalent