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目的比较两种奥替溴铵胶囊在健康人体内的药动学和生物等效性。方法 21名中国健康男性受试者随机交叉单次口服奥替溴铵胶囊受试制剂和参比制剂80 mg后,采用经验证的高效液相色谱-质谱联用法测定血浆中的奥替溴铵的浓度,采用DAS 2.1.1软件计算药动学参数并进行生物等效性统计分析。结果受试者单次口服受试制剂和参比制剂后,血浆中奥替溴铵的ρmax、tmax和AUC0-t分别为(5.252±4.581)和(4.372±2.410)ng·m L-1、(1.5±0.9)和(1.5±1.1)h、(21.51±18.60)和(20.40±10.74)ng·h·m L-1,受试制剂的ρmax和AUC0-24的90%置信区间在参比制剂的生物等效范围之内。结论两种奥替溴铵胶囊在人体内具有生物等效性。
Objective To compare the pharmacokinetics and bioequivalence of two oltipran capsules in healthy volunteers. Methods Twenty-one Chinese healthy male subjects were randomized to receive a single dose of oltipraz (80 mg) and a reference formulation (80 mg) orally in a randomized, double-blind, controlled, high- The pharmacokinetic parameters were calculated using DAS 2.1.1 software and bioequivalence statistical analysis was performed. Results After a single oral administration of the test preparation and the reference preparation, otmax, tmax and AUC0-t of otibronium bromide in plasma were (5.252 ± 4.581) and (4.372 ± 2.410) ng · m L-1, (1.5 ± 0.9) and (1.5 ± 1.1) h, (21.51 ± 18.60) and (20.40 ± 10.74) ng · h · m L-1, respectively. The 90% confidence intervals of ρmax and AUC0-24 Within the bioequivalence of the formulation. Conclusions Both Otibromide capsules are bioequivalent in humans.