NL-OMON35125已完成不适用
A randomized, four-way crossover, comparative bio-availability study of branded (Neurontin®) and three generic 800 mg gabapentin labels in healthy subjects under fasting conditions. - Comparative bio-availability study with gabapentin.
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*male or female volunteer, 18-55 years of age;
- •*non-smoking (for at least 3 months) or moderately smoking, i.e. less than 10 cigarettes a day;
- •*weighing in the normal range according to accepted normal values of BMI Chart (18-30kg/m2);
- •*in a healthy condition, as assessed bij the investigator based on medical history, physical exam, vital signs, routine laboratiry tests and 12-lead ECG;
- •*females of childbearing potential should either be sexual inactive for 14 days prior to the first dose and throughout the study or be using an acceptable birth control method;
- •*voluntary consenting to participate in the study.
排除标准
- •*history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease;
- •*a positive test result for HIV, hepatitis B and C;
- •*history or presence of alcoholism or drug abuse within the past year or hypersensitivity or idiosyncratic reaction to gabapentin or any other anticonvulsive agents;
- •*female subjects who are pregnant or lactating;
- •*subjects who have a variable, instable nutrition pattern;
- •*subjects who have donated blood within the last 2 months, or who have donated plasma within the last 14 days;
- •*subjects who have participated in another clinical trial within 28 days prior to start to the first dose.
研究者
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Gabapentin 800 mg tablets, four-way crossover, fasting bioavailability study in healthy subjects.In clinical practice, generic drugs (generics) are often interchanged, whereas factual data regarding generic-generic interchangeability are lacking. Under these conditions, the so-called ‘shift’ or ‘drift’ problem that may occur when generics are interchanged may be reason for concernwhile generics are exchangeable with the innovator product, generics themselves may not be, which may lead to loss of efficacy or increased toxicity. This problem may be relevant for certain drugs with a narrow therapeutic window, including anti-epileptic drugs, where seizure control may be lost or side-effects may increase when patients switch from one generic to another.NL-OMON25575Maastricht University Medical Center +P.O. Box 58006202 AZ MaastrichtThe NetherlandsTel: 043 388 1766Fax: 043 367 091624
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