Safety and the Pharmacokinetic Study of Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PharmaKing
• Treatments: Montelukast

Criteria

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)