A Relative Bioavailability Study of Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets Under Non-Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
研究概览
简要总结
The objective of this study is to compare the relative bioavailability of Losartan potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) with that of Hyzaar® 100/25 mg tablets (Merck) in healthy, adult, non-smoking subjects under non-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
- •Healthy, non-smoking, male and female subjects at least 18 years of age.
- •BMI (body mass index) of 30 or less.
- •Females in this study must be physically unable to become pregnant (postmenopausal for at least 6 months or surgically sterile).
- •Successful completion of a physical examination within 28 days of initiation of the study.
- •Negative serum pregnancy test (females).
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 outside the reference range and are deemed clinically significant by the Principle Investigator.
- •Subjects who have a history of allergic responses to the classes of drugs being tested will be excluded from the study.
- •Subjects who use tobacco in any form will not be eligible to participate in the study. 3 months abstinence is required.
- •Subjects found to have urine concentrations of any of the tested drugs of abuse 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.
- •Subjects who have taken any investigational drug within 30 days prior to the first dosing of the study will not be allowed to participate.
- •Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study 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 not tolerate venipuncture will not be allowed to participate.
研究组 & 干预措施
Generic Test Product
Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets
干预措施: Losartan potassium/Hydrochlorothiazide (Drug)
Reference Listed Drug
Hyzaar® 100/25 mg Tablets
干预措施: Losartan potassium/Hydrochlorothiazide (Drug)
结局指标
主要结局
Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
时间窗: Blood samples collected over a 48 hour period.
Bioequivalence based on Hydrochlorothiazide Cmax.
AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
时间窗: Blood samples collected over a 48 hour period.
Bioequivalence based on Losartan AUC0-t.
AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)
时间窗: Blood samples collected over a 48 hour period.
Bioequivalence based on Losartan AUC0-inf.
AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
时间窗: Blood samples collected over a 48 hour period.
Bioequivalence based on Hydrochlorothiazide AUC0-t.
AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)
时间窗: Blood samples collected over a 48 hour period.
Bioequivalence based on Hydrochlorothiazide AUC0-inf.
Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)
时间窗: Blood samples collected over a 48 hour period.
Bioequivalence based on Losartan Cmax.
次要结局
未报告次要终点