A Randomized, Open-label, Three-period, Three-sequence, Crossover, Single-dose Bioequivalence Study of Montelukast Sodium Oral Thin Films in Healthy Chinese Volunteers Under Fasted Condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This study aimed to evaluate the pharmacokinetic characteristics of montelukast sodium oral thin films and the bioequivalence between oral thin films and chewable tablets in healthy chinese volunteers under fasted condition.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fully understood and voluntarily signed the informed consent form
- •With high compliance
- •BMI 18.6-28.5 kg/m^2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female
排除标准
- •Allergic to any component of study drugs, other leukotriene receptor antagonists, sulfonamides, or non-steroidal anti-inflammatory drugs
- •With clinically relevantly abnormal vital sign, examination, or clinically relevant disease
- •Had drug abuse within 3 months before screening or positive in drug of abuse test
- •With any routine use of drugs
- •Received major surgery within 6 months before study drug administration or planned to receive major surgery during study period
- •With average number of cigarettes smoked > 5/day within 3 months before screening or refused to suspend smoking from 24 hours before study drug administration throughout study period
- •With average alcohol consumption > 14 units/week within 6 months before screening or refused to suspend alcohol consumption from 24 hours before study drug administration throughout study period
- •With average tea, coffee, or other drink with caffeine consumption > 8*250 mL/day, or refused to suspend tea, coffee, other drink with caffeine, or grape fruit juice consumption from 24 hours before study drug administration throughout study period
- •Lost or donated blood > 200 mL within 3 months, or donated platelet > 24 U within 1 months before study drug administration
- •Received any drug within 14 days before study drug administration
- •Received any drug of other clinical trial within 3 months before study drug administration
- •Received any vaccine within 4 weeks before study drug administration
- •Planned for pregnancy within 3 months after informed consent form signed or refused to use adequate contraception (excluding contraceptive drug)
- •For female, pregnant, breastfeeding, received oral contraceptives within 30 days, or contraceptive injection or implant within 6 months before study drug administration
- •For pregnancy-capable female, had unprotected sexual contact within 14 days before study drug administration
研究组 & 干预措施
ABC
Administration order: montelukast sodium oral thin films without water, montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water.
干预措施: Montelukast sodium oral thin films without water (A) (Drug)
ABC
Administration order: montelukast sodium oral thin films without water, montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water.
干预措施: Montelukast sodium oral thin films with water (B) (Drug)
ABC
Administration order: montelukast sodium oral thin films without water, montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water.
干预措施: Montelukast sodium chewable tablets with water (C) (Drug)
BCA
Administration order: montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water, montelukast sodium oral thin films without water.
干预措施: Montelukast sodium oral thin films without water (A) (Drug)
BCA
Administration order: montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water, montelukast sodium oral thin films without water.
干预措施: Montelukast sodium oral thin films with water (B) (Drug)
BCA
Administration order: montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water, montelukast sodium oral thin films without water.
干预措施: Montelukast sodium chewable tablets with water (C) (Drug)
CAB
Administration order: montelukast sodium chewable tablets with water, montelukast sodium oral thin films without water, montelukast sodium oral thin films with water.
干预措施: Montelukast sodium oral thin films without water (A) (Drug)
CAB
Administration order: montelukast sodium chewable tablets with water, montelukast sodium oral thin films without water, montelukast sodium oral thin films with water.
干预措施: Montelukast sodium oral thin films with water (B) (Drug)
CAB
Administration order: montelukast sodium chewable tablets with water, montelukast sodium oral thin films without water, montelukast sodium oral thin films with water.
干预措施: Montelukast sodium chewable tablets with water (C) (Drug)
结局指标
主要结局
Cmax
时间窗: 0-24 hours
The maximum plasma drug concentration
AUC0-t
时间窗: 0-24 hours
The area under the concentration-time curve from dosing to time t
AUC0-∞
时间窗: 0-24 hours
The area under the concentration-time curve extrapolated to infinity
次要结局
未报告次要终点