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目的：以英国施贵宝公司的索他洛尔片剂为对照，研究德国基诺公司研制的索他洛尔片剂的相对生物利用度和药代动力学。方法：以１２名男性健康志愿者为研究对象，采用自身对照法交叉口服单剂量索地洛尔１６０ｍｇ，ＨＰＬＣ法测定服药后不同时间血清中索他洛尔的药物浓度。结果：药物的体内过程经药代动力学程序拟合后，符合二室模型，其主要药代动力学参数如下：Ｃｍａｘ（１．１８±０．１９）ｍｇ／Ｌ；Ｔｍａｘ（３．０４±０．７５）ｈ；Ｔ１／２β（９．４６±２．４８）ｈ；ＡＵＣ０～∞（１３．３０±１．６０）（ｍｇ·ｈ）／Ｌ；相对生物利用度Ｆ＝（１０１．９６±１３．４１）％。结论：经统计学检验证实两种制剂生物等效。
OBJECTIVE: To compare the relative bioavailability and pharmacokinetics of sotalol tablets developed by Kenuo Company in Germany with sotalol tablets from British Squibb Company. Methods: A total of 12 male volunteers were enrolled in this study. A single dose of soxalol 160 mg was administered orally by self-control method. The concentrations of sotalol in serum at different time points were determined by HPLC. Results: The in vivo pharmacokinetics of the drug was fitted to a two-compartment model by pharmacokinetic procedure with the following pharmacokinetic parameters: Cmax (1.18 ± 0.19) mg / L; Tmax (3.04 ± 0.75) h; T1 / 2β (9.46 ± 2.48) h; AUC0 ~ ∞ (13.30 ± 1.60) (mg · h) / L; relative bioavailability F = (101.96 ± 13.41)%. Conclusion: Statistical tests confirmed the bioequivalence of the two preparations.