Cánovas M, Cabré F, Polonio F
Laboratorios Lesvi, S. L. - Invent Farma Group, Sant Joan Despí, Barcelona, Spain.
Drug Res (Stuttg). 2014 Jan;64(1):53-6. doi: 10.1055/s-0033-1353172. Epub 2013 Sep 18.
A bioequivalence study of 2 irbesartan (CAS 138402-11-6) film-coated tablet formulations was carried out in 40 healthy volunteers according to an open label, randomized, 2-period, 2-sequence, crossover, single dose and fasting conditions design. The test and reference formulations were administered in 2 treatment days, separated by a washout period of 7 days. Blood samples were drawn up to 96 h following drug administration. Plasma concentrations of irbesartan were obtained by a validated HPLC method using MS/MS detection. Log-transformed AUC0-t and Cmax values were tested for bioequivalence based on the ratios of the geometric LSmeans (test/reference). tmax was analysed nonparametrically. The 90% confidence intervals of the geometric LSmean values for the test/reference ratios for AUC0-t (98.06-109.48%, point estimator 103.61%) and Cmax (88.93-100.87%, point estimator 94.72%) were within the bioequivalence acceptance range of 80-125%. According to the European Guideline on the Investigation of Bioequivalence it may be therefore concluded that test formulation of irbesartan 300 mg film-coated tablet is bioequivalent to the reference formulation. Overall, it was judged that the study was conducted with a good tolerance of the subjects to both study drugs.
按照开放标签、随机、双周期、双序列、交叉、单剂量和禁食条件设计，在40名健康志愿者中开展了2种厄贝沙坦（化学物质登记号138402-11-6）薄膜包衣片制剂的生物等效性研究。在2个治疗日分别给予受试制剂和参比制剂，中间间隔7天的洗脱期。给药后采集血样至96小时。采用经验证的HPLC方法并结合MS/MS检测获得厄贝沙坦的血浆浓度。基于几何最小二乘均值（受试/参比）的比值，对经对数转换的AUC0-t和Cmax值进行生物等效性检验。对tmax进行非参数分析。AUC0-t（98.06-109.48%，点估计值103.61%）和Cmax（88.93-100.87%，点估计值94.72%）的受试/参比比值的几何最小二乘均值的90%置信区间在生物等效性可接受范围80-125%内。因此，根据欧洲生物等效性研究指南，可以得出结论：厄贝沙坦300mg薄膜包衣片的受试制剂与参比制剂生物等效。总体而言，判断该研究中受试者对两种研究药物的耐受性良好。
