NCT02029313已完成1 期
A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium) Tablet 10mg in Healthy Male Korean Subjects
PharmaKing1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年11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
- 40
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse event
研究概览
简要总结
The Purpose of A center, Randomized, Open label, single dose, Placebo-controlled, 2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic Characteristics of MKT-N2 (Montelukast) and Singulair® (montelukast sodium) tablet 10mg in Healthy Male Korean Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Korean Male over20, under 45 years old
- •55kg over weight, IBW +-20% range male
排除标准
- •Males who have gotten a clinically significant of liver, pancreas, kidneys, nervous system, respiratory system, endocrine system, blood cancer, mental illness, cardiovascular, urinary tract disease, or a history corresponding
- •Males who have gotten a history of gastrointestinal disease
- •Males who have gotten a history of hypersensitivity to montelukast or reaction to other drugs(aspirin, antibiotics)
研究组 & 干预措施
MKT-N2
Experimental
Montelukast
干预措施: Montelukast (Drug)
MKT-N2
Experimental
Montelukast
干预措施: Montelukast sodium (Drug)
Singulair
Active Comparator
Montelukast sodium
干预措施: Montelukast (Drug)
Singulair
Active Comparator
Montelukast sodium
干预措施: Montelukast sodium (Drug)
结局指标
主要结局
Number of participants with Adverse event
时间窗: 1day
次要结局
- Pharmacokinetic profiles(1day)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fed ConditionFedNCT01567501IPCA Laboratories Ltd.28
已完成
1 期
Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fasting ConditionFasting StateNCT01557439IPCA Laboratories Ltd.28
Unknown
1 期
A Single Dose Bioequivalence Study of WD-1602 Versus Pradaxa® in Healthy Subjects Under Fed ConditionAnticoagulantNCT04592822Hong Kong WD Pharmaceutical Co., Limited20
已完成
1 期
Safety and Pharmacokinetic Characteristics of DKF-313Benign Prostate HyperplasiaHealthyNCT02352311Dongkook Pharmaceutical Co., Ltd.54
已完成
1 期
Oral Bio-equivalence StudyBioequivalenceSafetyNCT05145621Alembic Pharmaceuticals Ltd.26