NCT01132170已完成1 期
An Open Label, Balanced, Randomized, 2-treatment, 2-period, 2-sequence, Single Dose, Crossover, Bioequivalence Study of Divalproex Sodium DR 500 mg Tablets and Depakote® DR 500 mg Under Fasting Conditions.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Bioequivalence based on Cmax and AUC parameters
研究概览
简要总结
The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets 500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy subjects.
详细描述
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex sodium DR 500 mg tablets of Dr.Reddy's Laboratories Limited, Generics, India comparing with that of Depakote® DR (containing Divalproex sodium) 500 mg tablets of Abbott Laboratories PR Ltd., Barceloneta, PR, in healthy, adult, human subjects under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
- •Subjects who will provide written informed consent.
- •Subjects must be healthy, adult, human beings within 18-45 years of age (both inclusive)weighing at least 50 kg.
- •Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2
- •Subjects must be of normal health as determined by medical history and physical examination performed within 21 days prior to the commencement of the study.
- •Subjects whose screening laboratory values are within normal limits or considered by the physician/investigator to be of no clinical significance.
- •Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by written informed consent.
排除标准
- •The subjects will be excluded based on the following criteria during screening and during the study
- •Subjects incapable of understanding the informed consent.
- •Subjects who have:
- •Systolic blood pressure less than 90 mm of Hg and more than 140 mm of Hg
- •Diastolic blood pressure less than 60 mm of Hg and more than 94 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician/investigator.
- •Pulse rate below 50/min and above 100/min.
- •History of hypersensitivity or idiosyncratic reaction to Divalproex sodium or any other related drugs.
- •Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
- •Consumption of grapefruit for the past ten days prior to the dosing day until the completion of the study.
- •Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking from 48 hours before dosing and during sampling period
- •Subjects who have taken over the counter or prescribed medications and enzyme modifying or any systemic medication for during the last 7 and 30 days respectively before dosing.
- •Subjects who have participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
- •Subjects with clinically significant abnormalities (such as Laboratory Findings, ECG, X-Ray,Drugs of abuse, Alcohol etc.,) and/or with significant diseases (such as HIV, HCV, Syphilis,Hepatitis B etc.,).
- •Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study.
研究组 & 干预措施
Divalproex Sodium DR Tablets 500 mg
Experimental
Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Laboratories Limited
干预措施: Divalproex Sodium (Drug)
Depakote DR 500 mg Tablets
Active Comparator
Depakote DR 500 mg Tablets of Abbott Laboratories PR Ltd.,
干预措施: Divalproex Sodium (Drug)
结局指标
主要结局
Bioequivalence based on Cmax and AUC parameters
时间窗: 4 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Bioequivalence Study of Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Under Fed ConditionsHealthyNCT01132196Dr. Reddy's Laboratories Limited34
已完成
1 期
To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed ConditionsEpilepsyBipolar DisorderNCT00913848Sandoz30
已完成
1 期
To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting ConditionsEpilepsyBipolar DisorderNCT00913874Sandoz30
已完成
1 期
Divalproex Sodium Delayed-Release Tablets Under Fasting ConditionsHealthyNCT00834639Teva Pharmaceuticals USA24
已完成
1 期
Divalproex Sodium Delayed-Release Tablets Under Non-Fasting ConditionsHealthyNCT00834990Teva Pharmaceuticals USA24