NCT01244100已完成1 期
Food-Effect Pharmacokinetic Study of PL2200
PLx Pharma1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
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
- Effect of food by ratio of least-squares means (LSM) of the pharmacokinetic (PK) parameter of AUC0-t of the primary metabolite, salicylic acid, in the fed state versus the fasted state.
研究概览
简要总结
This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy normal male and female volunteers between 21 and 65 years of age.
排除标准
- •Abnormal findings on physical examination or clinical laboratories, or significant medical history.
- •Subject with hypersensitivity or contraindications to aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drug (NSAID).
研究组 & 干预措施
PL2200
Experimental
干预措施: PL2200 fasted (Drug)
PL2200
Experimental
干预措施: PL2200 fed (Drug)
结局指标
主要结局
Effect of food by ratio of least-squares means (LSM) of the pharmacokinetic (PK) parameter of AUC0-t of the primary metabolite, salicylic acid, in the fed state versus the fasted state.
时间窗: 24 hours
Effect of food by ratio of least-squares means (LSM) of the PK parameter of AUC0-inf of the primary metabolite, salicylic acid, in the fed state versus the fasted state.
时间窗: 24 hours
Effect of food by ratio of least-squares means (LSM) of the PK parameter of Cmax of the primary metabolite, salicylic acid, in the fed state versus the fasted state.
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...
相似试验
已完成
1 期
A Study to Evaluate the Effect of Food on LY2216684Depressive Disorder, MajorNCT01389765Eli Lilly and Company24
已完成
1 期
A Study of LY2157299 in Healthy ParticipantsHealthy VolunteersNCT01965808Eli Lilly and Company16
已完成
1 期
A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy SubjectsHealthyNCT01334242Lexicon Pharmaceuticals14
已完成
2 期
The Effect of Various Amounts of Fat on PK of Oral Testosterone UndecanoateHypogonadismNCT02921386Clarus Therapeutics, Inc.18
已完成
1 期
Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate HypertensionHypertensionNCT00933920Novartis Pharmaceuticals124