An Open Label, Balanced, Randomized, Two-treatment, Single-dose, Crossover, Bioequivalence Study of Divalproex Sodium Coated Particles in Capsules, 125 mg With Depakote® Sprinkle 125 mg in Healthy Human Subjects Under Fasting Conditions.
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
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with Depakote® Sprinkle125 mg capsules in healthy, adult, human subjects under fasting conditions.
详细描述
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium Capsules (Sprinkle), 125 mg of Dr.Reddy's Laboratories Limited,comparing with that of Depakote® Sprinkle 125 mg capsules of Abbott Laboratories, USA in healthy, adult, human subjects under fasting conditions with an adequate washout period of 10 days.
The subjects were given a single oral dose of medication (test study or reference medication) . The capsule was opened and all the contents were sprinkled over a spoonful of applesauce without a spillage and administered to the subjects.
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 or more than 140 mm of Hg
- •Diastolic blood pressure less than 60 mm of Hg or 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 or above 100/min.
- •History of hypersensitivity or idiosyncratic reaction to Investigational drug products 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.
- •Subj eets 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
Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
干预措施: Divalproex Sodium (Drug)
Depakote Sprinkle
Depakote Sprinkle 125 mg capsules of Abbott Laboratories, USA
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: 2 months
次要结局
未报告次要终点