NCT00966641已完成1 期
"A Single-Dose Crossover Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adult Volunteers in the Fasted State"
PLx Pharma1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2009年8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
- 34
- 试验地点
- 1
- 主要终点
- Area Under the Curve of Plasma Naproxen From 0 to t
研究概览
简要总结
The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75 years, inclusive.
- •Subject has a Body Mass Index (BMI) between 20 and 32, inclusive.
- •Normal physical examination as determined by the Investigator.
- •Normal clinical laboratory test results or clinically insignificant results as determined by the Investigator during the screening visit.
- •If female and of child-bearing potential, the subject must have a negative pregnancy test and is not nursing.
- •If female and of child-bearing potential, the subject must agree to use adequate birth control for the duration of the study.
排除标准
- •Subject has a history of chronic alcohol consumption or abuse of narcotics or alcohol.
- •Subject has had an acute illness within 5 days of study medication administration.
- •Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.
- •Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.
研究组 & 干预措施
Naproxen
Active Comparator
Active comparator
干预措施: Naproxen (Drug)
PL 3100
Experimental
Active experimental drug
干预措施: PL 3100 (Drug)
结局指标
主要结局
Area Under the Curve of Plasma Naproxen From 0 to t
时间窗: 30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.
Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.
次要结局
未报告次要终点
研究者
研究点 (1)
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