An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered Following Various Caloric Intakes 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
- Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf)
研究概览
简要总结
The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.
详细描述
To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled release formulation following various sized caloric meals relative to the immediate release formulation.
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
330 mg pregabalin controlled release: 400 to 500 calories
干预措施: 330 mg pregabalin controlled release (Drug)
330 mg pregabalin controlled release: 600 to 750 calories
干预措施: 330 mg pregabalin controlled release (Drug)
330 mg pregabalin controlled release: 800 to 1000 calories
干预措施: 330 mg pregabalin controlled release (Drug)
300 mg pregabalin immediate release
干预措施: 300 mg pregabalin immediate release (Drug)
结局指标
主要结局
Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf)
时间窗: 3 days
次要结局
- Adverse events, vital signs, and clinical safety laboratories.(3 days)