摘要
目的:研究国产格列齐特片(Ⅱ)在正常人体内的相对生物利用度。方法:20例健康志愿者随机分为两组,分别交叉口服国产格列齐特片(Ⅱ)和合资产品格列齐特片,采用反相高效液相色谱法测定血浆中药物浓度,并计算受试片的主要药动学参数及相对生物利用度。结果:受试制剂和参比制剂的T_(max)分别为(7.9±0.9)和(8.0±0.4)h,C_(max)分别为(3.44±1.01)和(3.24±0.97)mg·L^(-1),用梯形法计算所得的AUC_(0～48)分别为(47.32±9.60)和(47.73±10.83)mg·h·L^(-1);经t检验,两种剂型的药动学差异无显著性;与参比制剂相比,受试制剂的相对生物利用度为(100.3±12.2)%。结论:两种制剂具有生物等效性。
Objective: To assess the relative bioavailability of domestic gliclazide tablets (Ⅱ). Methods: In a randomized, single-dose, open-label and crossover study, the plasma gliclazide concentrations collected from 20 healthy volunteers that randomly received domestic (test) or joint-adventure manufactured (reference) gliclazide tablets (80mg) were measured by RP-HPLC. Results: The pharmacokinetic parameters of test and reference tablets were as follows: T_(max)(7.9±0.9) vs (8.0±0.4)h; C_(max)(3.44±1.01) vs (3.24±0.97)mg·L^(-1); AUC_(0-48)(47.32±9.60) vs (47.73±10.83) mg·h·L^(-1). No statistical difference was found in the parameters of two tablets. The relative bioavailability of test tablets (Ⅱ)was (100.3±12.2)%. Conclusion: Two gliclazide tablets were bioequivalent.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2005年第6期750-752,共3页
Chinese Journal of New Drugs
