NCT00647621已完成1 期
Steady-State Bioequivalence Study of Extended Phenytoin Sodium Capsules (100 mg; Mylan) and Dilantin® Kapseals® (100 mg; Pfizer) in Healthy Adult Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 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 steady-state bioequivalence of Mylan's extended phenytoin sodium capsules, 100mg (3x100mg), to Pfizer's Dilantin® Kapseals®, 100mg (3x100mg), under both fasting and fed conditions.
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
- •Age: 18 years and older.
- •Sex: Male and/or females of non-childbearing potential.
- •Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- •postmenopausal with an absence of menses for at least one (1) year, or
- •bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
- •total hysterectomy
- •During the course of the study, from study screen until study exit - including the washout period, men must use a spermicide containing barrier method of contraception. This advice should be documented in the informed consent form.
- •Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of their 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, laboratory evaluation, Hepatitis B and Hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 21 days of the initial dose of study medication.
排除标准
- •Institutionalized subjects will not be used.
- •Social Habits:
- •Use of any tobacco-containing products within 1 year of the start of the study.
- •Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 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 the 14 days prior to the initial dose of study medication.
- •Use of any hormone replacement therapy within 3 months prior to study medication dosing.
- •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, or 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.
- •History of porphyria.
- •History of diabetes.
- •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 phenytoin or any other hydantoins.
- •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
Extended Phenytoin Sodium Capsules 100 mg
干预措施: Extended Phenytoin Sodium Capsules 100 mg (Drug)
2
Active Comparator
Dilantin® Kapseals® 100 mg
干预措施: Dilantin® Kapseals® 100 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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