Effect of Pineapple Juice on the Pharmacokinetics of Celecoxib and Montelukast in Humans
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The terminal elimination half-life (t1/2)
研究概览
简要总结
Pineapple (Ananas comosus) is a tropical fruit that is rich in antioxidents, enzymes and vitamins. It is used worldwide due to their anti-inflammatory and analgesic properties. The effect of pineapple Juice on the Pharmacokinetics of celecoxib and montelukast in Humans was studied.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects (body mass index between 21 to 25 kg/m2).
排除标准
- •Drug abuse.
- •Abnormal level of kidney or liver functions.
研究组 & 干预措施
Celecoxib
Twelve healthy male subjects participated in this arm under fasting condition. A randomized, open-label, 2-way crossover study design with 2-week washout period between treatments was used. Participants received a single oral dose of celecoxib tablets (100mg) after pre-treatment with 250ml of either pineapple juice or water (control) for four consecutive days before the beginning of the study.
干预措施: Celecoxib 100mg (Drug)
Montelukast
Twelve healthy male subjects participated in this arm under fasting condition. A randomized, open-label, 2-way crossover study design with 2-week washout period between treatments was used. Participants received a single oral dose of Montelukast tablets (10mg) after pre-treatment with 250ml of either pineapple juice or water (control) for four consecutive days before the beginning of the study.
干预措施: Montelukast 10mg (Drug)
结局指标
主要结局
The terminal elimination half-life (t1/2)
时间窗: 12 weeks
The area under the concentration-time curve from zero to infinity (AUC0-∞)
时间窗: 12 weeks
Time to reach plasma peak concentration [Tmax]
时间窗: 12 weeks
Maximum Plasma Concentration [Cmax]
时间窗: 12 weeks
Time to reach maximum plasma concentration [Tmax]
时间窗: 12 weeks
次要结局
- Clearance (CLT/F)(12 weeks)
研究者
Sally Helmy, PhD, CPHQ
Associate professor
Damanhour University