Safety and the Pharmacokinetic Study of Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma
Phase 1
Completed
- Conditions
- Asthma and Allergic Rhinitis
- Interventions
- Registration Number
- NCT02029313
- Lead Sponsor
- PharmaKing
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
- Healthy Korean Male over20, under 45 years old
- 55kg over weight, IBW +-20% range male
Exclusion Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description MKT-N2 Montelukast Montelukast Singulair Montelukast Montelukast sodium Singulair Montelukast sodium Montelukast sodium MKT-N2 Montelukast sodium Montelukast
- Primary Outcome Measures
Name Time Method Number of participants with Adverse event 1day
- Secondary Outcome Measures
Name Time Method Pharmacokinetic profiles 1day Blood evaluation variables: Cmax, AUCt (t=24 h), AUC∞, tmax
Trial Locations
- Locations (1)
Inha University Hospital
🇰🇷Incheon, Junggu, Korea, Republic of