尼扎替丁片在健康人体的药代动力学及生物等效性研究

Pharmacokinetics and relative bioavailability of nizatidine tablet in health volunteers

目的 研究尼扎替丁片在健康人体的药代动力学和生物等效性。方法 采用随机开放双交叉自身对照试验 ,2 2名健康自愿者单剂量口服尼扎替丁 (片或胶囊 ) 15 0mg ,用高效液相色谱法测定尼扎替丁在血浆中的浓度。结果 尼扎替丁片达峰时间为 (1 2 61± 0 3 66)h ,峰浓度为 (110 5 62 6± 187 3 78)ng/ml ,曲线下面积为 (3 83 2 5 98± 43 1 3 11)ng·h·ml-1,尼扎替丁胶囊达峰时间为 (1 0 91± 0 3 82 )h ,峰浓度为 (13 71 916± 2 80 980 )ng/ml,曲线下面积为 (3 978 2 2 7± 611 3 87)ng·h·ml-1。统计检验结果表明各药动学参数间均无显著性差异 (P >0 0 5 )。尼扎替丁片的相对生物利用度为 97 4%。结论 健康人单剂量口服 15 0mg尼扎替丁片与尼扎替丁胶囊生物等效。

Objective To study the pharmacokinetics and relative bioavailability of nizatidine tablets in healthy volunteers. Methods Nizatidine tablets or nizatidine capsules at the single dose of 150 mg were administered orally in 22 healthy volunteers in an open randomized cross-over test. The plasma levels of nizatidine were measured by high performance liquid chromatography (HPLC). Results The pharmacokinetic parameters of nizatidine tablets were: AUC 0-Tn (3 832.598±431.311) ng·h·ml -1, C max (1 105.626±187.378) ng·ml -1, and T max (1.261±0.366) h, and the pharmacokinetic parameters of nizatidine capsule were: AUC 0-Tn (3 978.227±611.387) ng·h·ml -1, C max (1 371.916±280.980) ng·ml -1, and T max (1.091±0.382) h. The statistical analysis for AUC 0-Tn, C max, and T max showed that there was no significant difference between nizatidine tablets and capsules (P>0.05). The relative bioavailability of nizatidine tablets was 97.4%. Conclusion The bioavailability of nizatidine tablets is equal to that of nizatidine capsules.