An Open-Label, Multiple-Dose, Randomized, 3-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of The 165 Mg And 330 Mg Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal And 150 Mg Of The Immediate Release Formulation Administered Twice Daily
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
- AUC24 and maximum plasma concentration over a 24 hour period (Cmax) at steady-state for assessment of equivalence between the 165 mg CR (two tablets administered concurrently) and 330 mg CR
研究概览
简要总结
The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.
详细描述
Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release 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, 165 mg
干预措施: Pregabalin controlled release, 165 mg (Drug)
Pregabalin controlled release, 330 mg
干预措施: Pregabalin controlled release, 330 mg (Drug)
Pregabalin immediate release, 150 mg
Reference Treatment
干预措施: Pregabalin immediate release, 150 mg (Drug)
结局指标
主要结局
AUC24 and maximum plasma concentration over a 24 hour period (Cmax) at steady-state for assessment of equivalence between the 165 mg CR (two tablets administered concurrently) and 330 mg CR
时间窗: 5 days
Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 330 mg CR and 150 mg IR (total daily dose 300 mg)
时间窗: 5 days
次要结局
- Safety endpoints include evaluation of adverse events.(5 days)