A Relative Bioavailability Study of Lansoprazole 30 mg DR Capsules Under Fasting Conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
研究概览
简要总结
The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, 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
- 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
- •Non-smokers or light smokers (10 or less cigarettes per day)
- •18 years of age or older
- •Body Mass Index of 30 or less
- •Males or non-pregnant females
- •Normal clinical laboratory test results
排除标准
- •Subjects with a significant 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 the 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 to not be significant.
- •Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
- •Subjects who are heavy users of tobacco (smoke more than 10 cigarettes a day, smoke cigars or pipes, or use oral tobacco products) will not be eligible to participate in the study. Light smokers may participate, but can not smoke from 2 hours before dosing until 2 hours after dosing.
- •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 30 days prior to the first dosing of the study.
- •Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allow 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. Female subjects who have used hormonal oral contraceptives within 180 days of dosing will not be allowed to participate.
- •Female subjects with a positive or inconclusive pregnancy test result will be withdrawn from the study.
- •Subjects who do not tolerate venipuncture will not be allowed to participate.
研究组 & 干预措施
Invesigational Test Product
Lansoprazole 30 mg delayed-release Capsules
干预措施: Lansoprazole (Drug)
Reference Listed Drug
Prevacid® 30 mg delayed-release Capsules
干预措施: Prevacid® (Drug)
结局指标
主要结局
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
时间窗: Blood samples collected over a 12 hour period.
Bioequivalence based on Cmax.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
时间窗: Blood samples collected over a 12 hour period.
Bioequivalence based on AUC0-t.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
时间窗: Blood samples collected over a 12 hour period.
Bioequivalence based on AUC0-inf.
次要结局
未报告次要终点