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

PharmaKing

Status and phase: Completed; Phase 1

Conditions: Asthma and Allergic Rhinitis

Treatments: Drug: Montelukast; Drug: Montelukast sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT02029313

PMK-M01RS1

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

40 participants in 2 patient groups

MKT-N2

Experimental group

Description:

Montelukast

Treatment:

Drug: Montelukast sodium

Drug: Montelukast

Singulair

Active Comparator group

Description:

Montelukast sodium

Treatment:

Drug: Montelukast sodium

Drug: Montelukast