An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Evaluate The Effects Of Caloric Content And Time Of Dosing On The Pharmacokinetics Of Pregabalin Controlled Release Formulation As Compared To The Immediate Release Formulation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments
研究概览
简要总结
The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release (CR) tablet administered a) fasted at bedtime, b) immediately following a 400 to 500 calorie evening meal, and c) immediately following a 600 to 750 calorie evening meal as compared to a single dose of the pregabalin immediate release (IR)capsule, 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet administered with various caloric sized dinners and at bedtime as compared to a single dose of the pregabalin immediate release capsule.
详细描述
Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or females
- •Between the ages of 18 and 55 years, inclusive
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
排除标准
- •Illicit drug use
- •Pregnant or nursing females
- •Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
研究组 & 干预措施
Pregabalin controlled release, 330 mg, 400-500 calorie
干预措施: Pregabalin controlled release, 330 mg, 400 to 500 calorie (Drug)
Pregabalin controlled release, 330 mg, 600- 750 calorie
干预措施: Pregabalin controlled release, 330 mg, 600- 750 calorie (Drug)
Pregabalin controlled release, 330 mg, bedtime
干预措施: Pregabalin controlled release, 330 mg, bedtime (Drug)
Pregabalin immediate release, 300 mg
Reference Treatment
干预措施: Pregabalin immediate release, 300 mg (Drug)
结局指标
主要结局
Area under the curve from 0 to infinity (AUCinf) for assessment of equivalence between the controlled release treatments and the immediate release treatments
时间窗: 3 days
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(3 days)