Dataset from 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.

本试验为一项开放标签、随机、单剂量、两序列两周期交叉研究，两个周期间设置7天洗脱期。本研究旨在评估健康成人空腹状态下，单次口服伊达唑（Idiazole）20毫克（mg）迟释（delayed release, DR）片剂与波利特（PARIET）20mg迟释片剂中雷贝拉唑（Rabeprazole）的生物利用度，具体通过测定生物等效性参数的对数转换比值（试验制剂/参比制剂）的90%置信限开展考察。将采用方差分析（ANOVA）检验序列、制剂及周期效应的影响。本试验计划纳入60名受试者，另追加1-4名受试者，按每组30人分为A、B两组。每名受试者共计完成33次采血，整个研究的总采血量不超过300毫升（mL）。PARIET为卫材株式会社（EISAI Co. Limited）注册商标。