NCT02103647已完成1 期
A Randomized, Open-label, Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation After Multiple Dosing Under Fasted Condition in Healthy Male Subjects
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
- 24
- 试验地点
- 1
- 主要终点
- Measure blood concentration of pregabalin
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg * 2) while multiple dosing.
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
- 19 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •19~44 aged healthy adult.
- •someone tho has at least 50kg body weight and ideal body weight ±20%
排除标准
- •someone has acute symptom at screening phase
- •someone has any disease or symptoms which is clinically significant
- •someone had been determined during healthy examination in screening period
- •AST or ALT > 1.25 times than normal
- •Total bilirubin > 1.5 times than normal
- •someone who has a history of allergy, anaphylaxis, drug abuse or misuse.
- •someone who had enrolled to other clinical trial within the last 60 days.
- •someone who had donated blood within the last 60 days.
- •someone who can't take a meal derived from this trial.
- •someone who has taken abnormal meals like which can affect to drug ADME
- •someone who has taken other ETC drugs or oriental drugs within the last 14 days, Or OTC drugs within the last 7 days
- •someone who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or took caffein since 24hours before.
- •someone who has taken alcohol more than 30g/day or smoked more than 10 piece of tobacco/day.
- •someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
研究组 & 干预措施
Immediate release capsule(lyrica capsule 150mg)
Active Comparator
Immediate release capsule repeat treatment for 3days under fasted condition
干预措施: Immediate release capsule(lyrica 150mg * 2/day) (Drug)
sustained release tablet
Experimental
sustained release tablet repeat treatment for 3days under fasted condition
干预措施: sustained release tablet (Drug)
结局指标
主要结局
Measure blood concentration of pregabalin
时间窗: 0~4day / 14~18day
次要结局
- Safety evaluation(0~25day)
研究者
研究点 (1)
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