Comparative Randomized, Single Dose, Two-way Crossover Open-label Study to Determine the Bioequivalence of Rabeprazole From Idiazole 20mg DR Tabs (GSK, Egypt)and PARIET 20 mg DR Tabs (JANSSEN, EGYPT) After a Single Oral Dose Administration of Each to Healthy Adults Under Fasting Conditions

This is an open-label, randomized, single dose, two-sequence, two-period crossover study, separated by 7 days washout interval from the first study drug administration. In this study, the bioavailability of Rabeprazole from Idiazole 20 milligram (mg) delayed release (DR) tablets and PARIET 20 mg DR tablets after a single oral dose administration of each to healthy adults under fasting conditions, will be investigated by determining the 90% confidence limits for the log-transformed ratio (Test product / Reference product) for the bioequivalence parameters. The influence of sequence, product and period effect will be tested by analysis of variance (ANOVA). In this study a total of 60 subjects plus 1-4 additional subjects will be enrolled and split into two groups (Group A and B) of 30 each. For each subject, a total of 33 blood draws will be done and the volume of blood will not exceed 300 milliliters (mL) for the study. PARIET is a registered trademark of EISAI Co. Limited.

本研究为一项开放标签、随机、单剂量两序列两周期交叉临床试验，两个周期之间设置7天洗脱期。本研究将针对健康成年受试者在空腹状态下单次口服给药后，比较伊达唑（Idiazole）20毫克（mg）延迟释放（delayed release, DR）片与PARIET 20mg DR片的雷贝拉唑（Rabeprazole）生物利用度，通过计算生物等效性参数的对数转换比值（试验制剂/参比制剂）的90%置信限开展研究。本研究将通过方差分析（analysis of variance, ANOVA）检验序列效应、制剂效应及周期效应的影响。本研究计划纳入共计60名受试者，外加1-4名补充受试者，并将其分为A、B两组，每组各30人。每名受试者共计采集33次血液样本，本研究总采血量不超过300毫升（mL）。PARIET为卫材（EISAI Co. Limited）注册商标。