An Open-Label, Multiple-Dose, Randomized, Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Three Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal 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
- 20
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax)
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 three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three 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 three pregabalin controlled release tablets as compared to multiple doses of the 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, 82.5 mg
干预措施: Pregabalin controlled release, 82.5 mg (Drug)
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
Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax)
时间窗: 5 days
The average plasma concentration at steady-state (Cav), half-life
时间窗: 5 days
Peak:trough ratio at steady-state (PTR), peak to trough fluctuation at steady-state (PTF), and peak:trough swing at steady-state (PTS)
时间窗: 5 days
Area under the curve at steady-state for a dosing interval (AUCτ), Dose-adjusted AUCτ
时间窗: 5 days
Minimum plasma concentration at steady-state within a dosing interval (Cmin)
时间窗: 5 days
次要结局
- Safety endpoints include evaluation of adverse events.(5 days)