泮托拉唑钠肠溶片在中国男性健康志愿者体内的药动学和相对生物利用度研究

目的:研究泮托拉唑钠肠溶试验片与参比片的药代动力学与相对生物利用度。方法:20名男性健康志愿者单剂量口服泮托拉唑钠试验和参比制剂各40mg;采用反相高效液相色谱法测定其血药浓度。用DAS软件计算药代动力学参数,考察其生物等效性。结果:泮托拉唑钠肠溶片在人体的药动学行为符合二房室开放模型,试验片与参比片的主要药代动力学参数:Tmax分别为(3.18±0.54)和(3.30±0.47)h;Cmax分别为(2.98±0.83)和(2.91±0.87)mg·L-1;T12分别为(1.86±0.41)和(1.72±0.48)h;AUC0-t分别为(9.51±3.71)和(9.77±4.55)mg·h·L-1;相对生物利用度为(102.3±19.6)%。结论:泮托拉唑钠肠溶片两种制剂具有生物等效性。

Pharmacokinetics and relative bioavailability of pantoprazole sodium enteric-coated tablets in healthy male Chinese volunteers

AIM: To study pharmacokinetics and relative bioavailability of pantoprazole sodium enteric-coated test and reference tablets in healthy volunteers. METHODS: A single oral dose of 40 mg pantoprazole sodium enteric-coated test and reference tablets were given to 20 male healthy volunteers in a randomized two-way crossover design. Plasma concentrations of pantoprazole were determined by HPLC method. Pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two preparations. RESULTS: Plasma concentration-time profiles were adequately described by a two-compartment open model. The main pharmacokinetic parameters of pantoprazole sodium test and reference tablets were as follow: The values of Tmax were (3.18±0.54) and (3.30±0.47) h, Cmax were (2.98±0.83) and (2.91±0.87) mg·L-1, T1/2β were (1.86±0.41) and (1.72±0.48) h, AUC0-t were (9.51±3.71) and (9.77±4.55) mg·h·L-1, respectively. The relative bioavailability of test tablets was (102.3±19.6)%. CONCLUSION: The two preparations of pantoprazole sodium are bioequivalent.