Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Rabeprazole From Idiazole 20mg DR Tabs (GSK, Egypt) and PARIET 20 mg DR Tabs (JANSSEN, EGYPT)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximal measured plasma concentration (Cmax)
研究概览
简要总结
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.
详细描述
Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.
A comprehensive final report will be issued upon the completion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female, age 18 to 55 years, inclusive.
- •Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
- •Medical demographics without evidence of clinically significant deviation from normal medical condition.
- •Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
- •Subject does not have allergy to the drugs under investigation.
排除标准
- •Subjects with known allergy to the products tested.
- •Subjects whose values of BMI were outside the accepted normal ranges.
- •Female subjects who are pregnant, nursing or taking birth control pills.
- •Medical demographics with evidence of clinically significant deviation from normal medical condition.
- •Results of laboratory tests which are clinically significant.
- •Acute infection within one week preceding first study drug administration.
- •History of drug or alcohol abuse.
- •Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
- •Subject is on a special diet (for example subject is vegetarian).
- •Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
- •Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
- •Subject has a history of severe diseases which have direct impact on the study.
- •Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
- •Subject intends to be hospitalized within 6 weeks after first study drug administration.
- •Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year
研究组 & 干预措施
Study group
60 subjects will receive a single oral dose of idiazole 20mg DR tabs under fasting condition in one period. And the subjects will receive a single dose of PARIET 20 mg DR tabs under fasting condition in the second period. A 7 days washout interval is in between the 2 periods
干预措施: Idiazole 20mg DR tabs (Drug)
Study group
60 subjects will receive a single oral dose of idiazole 20mg DR tabs under fasting condition in one period. And the subjects will receive a single dose of PARIET 20 mg DR tabs under fasting condition in the second period. A 7 days washout interval is in between the 2 periods
干预措施: PARIET 20 mg DR tabs (Drug)
结局指标
主要结局
Maximal measured plasma concentration (Cmax)
时间窗: Up to 14 hours post dose in each treatment period
Serial blood samples for determination of study drug will be collected pre-dose and at 0.00, 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.0, 5.33, 5.67, 6.00, 8.00, 12.0 and 14.0 hours post dose, relative to dosing on Day 1 in each cross over period.
Area under the plasma concentration-time curve from time zero to the last measurable concentration (t) (AUC [0 to t])
时间窗: Up to 14 hours post dose in each treatment period
(AUC \[0 to t\]) will be calculated by the linear trapezoidal method.
Area Under the plasma concentration-time curve from time zero to infinity (AUC [0 to infinity])
时间窗: Up to 14 hours post dose in each treatment period
AUC (0 to infinity) will be calculated as the sum of the AUC (0 to t) plus the ratio of the last measurable plasma concentration to the elimination rate constant
次要结局
- Time of the maximum plasma concentration (tmax)(Up to 14 hours post dose in each treatment period)
- Terminal half life (t1/2e)(Up to 14 hours post dose in each treatment period)
- Apparent first-order elimination or terminal rate constant (K¬e)(Up to 14 hours post dose in each treatment period)