NCT00648076已完成1 期
Single-Dose Food In Vivo Bioequivalence Study of Divalproex Sodium Extended-Release Tablets (500 mg; Mylan) to Depakote ER® Tablets (500 mg; Abbott) in Healthy, Adult Male Volunteers
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
- 40
- 试验地点
- 1
- 主要终点
- Bioequivalence
研究概览
简要总结
The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administered under fed conditions.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Age: 18 years and older.
- •Weight: At least 60 kg (132 lbs) and within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- •All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, including vital signs, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
- •During the course of the study, from study screen until study exit, all males must use a spermicide-containing barrier method of contraception in addition to their current contraceptive device (if any). This requirement should be documented in the informed consent form.
排除标准
- •Institutionalized subjects will not be used.
- •Social Habits:
- •Use of any tobacco products within 1 year of the start of the study.
- •Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within 48 hours prior to the initial dose of study medication.
- •Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- •Any recent, significant change in dietary or exercise habits.
- •A positive test for any drug included in the urine drug screen.
- •History of drug and/or alcohol abuse.
- •Medications:
- •Use of any prescription or over-the-counter (OTC) medications within 14 days prior to the initial dose of study medication.
- •Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- •History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
- •Acute illness at the time of either the pre-study medical evaluation or dosing.
- •A positive HIV, hepatitis B, or hepatitis C test.
- •Abnormal and clinically significant laboratory test results:
- •Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- •Abnormal and clinically relevant ECG tracing.
- •Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
- •Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- •Allergy or hypersensitivity to valproic acid or any other related products.
- •History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
- •Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
研究组 & 干预措施
1
Experimental
Divalproex Sodium Extended-Release Tablets 500 mg
干预措施: Divalproex Sodium Extended-Release Tablets 500 mg (Drug)
2
Active Comparator
Depakote ER® Tablets 500 mg
干预措施: Depakote ER® Tablets 500 mg (Drug)
结局指标
主要结局
Bioequivalence
时间窗: within 30 days
次要结局
未报告次要终点
研究者
研究点 (1)
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