NCT00729729已完成4 期
Phase 4, Three Way Cross-over, Pharmacokinetic Study for PCA Derivate Formulations in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PCA derivate blood levels
研究概览
简要总结
A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects who have completed the informed consent process culminating with written informed consent by the subject.
- •Age 18-45 years
- •Abstinence from alcohol for 1 week prior to the study
- •Non smoking
- •BMI > 19 and < 30
- •No history or evidence of significant
- •cardiovascular,
- •hematopoietic,
- •gastrointestinal disease,
- •endocrine,
- •metabolic,
- •psychiatric
- •psychological disorders
- •Normal physical examination
- •Within +/- 10% of normal values in laboratory examinations
排除标准
- •Subjects who suffer from a current medical condition.
- •Subjects who smoke.
- •Subjects who drink > 20 grams of alcohol per day.
- •Subjects who take prescription medication.
- •Subjects with an abnormality in screening blood tests
- •Known sensitivity to any ingredients in the study drug
研究组 & 干预措施
1
Placebo Comparator
Placebo
干预措施: PCA (Drug)
2
Experimental
Slow release PCA derivative
干预措施: PCA (Drug)
3
Experimental
Slow release PCA derivative higher dose
干预措施: PCA (Drug)
结局指标
主要结局
PCA derivate blood levels
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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