A Phase 1, Open-Label, Randomized, Cross-Over Study to Evaluate the Effects of Multiple Doses of Erythromycin on the Pharmacokinetics of a Single Dose of Pregabalin Controlled Release in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin
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 tablet with and without coadministration of erythromycin and 2) evaluate the safety and tolerability of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin.
详细描述
Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet with and without erythromycin
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
1
Single Dose Pregabalin Controlled Release
干预措施: Pregabalin controlled release, 330 mg (Drug)
2
Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin
干预措施: Pregabalin controlled release, 330 mg (Drug)
2
Single Dose Pregabalin Controlled Release with Multiple Doses of Erythromycin
干预措施: erythromycin (Drug)
结局指标
主要结局
Peak concentrations (Cmax) for assessment of equivalence between controlled released (CR) alone and CR with erythromycin
时间窗: 3 days
Area under the curve from 0 to infinity (AUCinf)
时间窗: 3 days
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(3 days)