A Relative Bioavailability Study of Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
研究概览
简要总结
The objective of this study is to compare the relative bioavailability of pantoprazole sodium 40 mg delayed-release tablets ( manufactured by TEVA Pharmaceuticals Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PROTONIX® 40 mg delayed-released tablets (Wyeth-Ayerst) in Healthy, adult, non-smoking subjects under fasting conditions.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI(Body Mass Index) of 30 or less.
排除标准
- •Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular, disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
- •Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result not to be significant.
- •Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
- •All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
- •Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study will not be allowed to participate.
- •Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate.
- •All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
- •Subjects who do no tolerate venipuncture will not be allowed to participate.
- •Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
研究组 & 干预措施
Pantoprazole
Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period
干预措施: Pantoprazole Sodium 40 mg delayed-release tablets (Drug)
Protonix®
Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period
干预措施: PROTONIX® 40 mg delayed-release tablets. (Drug)
结局指标
主要结局
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
时间窗: Blood samples collected over 16 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
时间窗: Blood samples collected over 16 hour period
Bioequivalence based on AUC0-t
Cmax - Maximum Observed Concentration - Pantoprazole in Plasma
时间窗: Blood samples collected over 16 hour period
Bioequivalence based on Cmax
次要结局
未报告次要终点