NCT00802035已完成1 期
A Phase 1, Single-Center, Open-Label Study of the Pharmacokinetics of Baclofen Formulations Administered to Healthy Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 and 65 years
- •Body mass index of 19 to 30 kg/m2 at screening
- •If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception for the duration of the study
排除标准
- •Pregnancy and/or currently breastfeeding
- •Clinical significant medical condition or observed abnormalities
- •Acute gastrointestinal disorder or history of chronic gastrointestinal disease or surgery
- •Participation in a clinical trial within 30 days before screening
- •Known intolerance and/or hypersensitivity to baclofen or its excipients
- •Use of alcohol-, caffeine-, or xanthine-containing products
- •Clinically significant illness within 30 days of first study drug administration
- •Dietary restrictions that conflict with required study meals
研究组 & 干预措施
IR am
Active Comparator
30 mg, single dose, morning administration (immediate release [IR])
干预措施: Baclofen IR (Drug)
ER am
Experimental
30 mg; single dose; morning administration (extended release [ER])
干预措施: Baclofen ER (Drug)
ER pm
Experimental
30 mg; single dose; evening administration
干预措施: Baclofen ER (Drug)
IR pm
Active Comparator
30 mg; single dose; evening administration
干预措施: Baclofen IR (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: 5 weeks
次要结局
- Significant abnormal laboratory findings(5 weeks)
- Area under the plasma concentration curve (AUC)(5 weeks)
- Time to Cmax(5 weeks)
研究者
研究点 (1)
Loading locations...
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