NCT00548678已完成1 期
Open-Label, Randomized, Single-Dose, Four-Treatment Crossover Study to Evaluate Platelet Function in Healthy Adult Males After Administration of IV Diclofenac Sodium, Oral Diclofenac Potasssium, IV Ketorolac Tromethamine, and Acetylsalicylic Acid
Javelin Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007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
- 30
- 试验地点
- 1
- 主要终点
- Area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100.
研究概览
简要总结
This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.
详细描述
The primary objective is to evaluate platelet function following intravenous diclofenac, oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects.
- •Willing and able to stay at the clinical site for approximately 8 nights over 9 days and to return to the clinic approximately 7 days after discharge.
排除标准
- •Bleeding abnormalities or cardiovascular events.
- •Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.
研究组 & 干预措施
A
Experimental
intravenous diclofenac sodium
干预措施: intravenous diclofenac sodium (DIC075V) (Drug)
C
Active Comparator
oral diclofenac (Cataflam)
干预措施: oral diclofenac (Cataflam) (Drug)
B
Active Comparator
intravenous ketorolac
干预措施: ketorolac (Drug)
D
Active Comparator
oral aspirin
干预措施: aspirin (Drug)
结局指标
主要结局
Area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100.
时间窗: 6 hours
次要结局
- The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100.(6 hours)
研究者
研究点 (1)
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