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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02029313

Enrollment

Registered

2014-01-07

Start date

2013-11-30

Completion date

2014-03-31

Last updated

2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma and Allergic Rhinitis

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

Interventions

DRUGMontelukast

DRUGMontelukast sodium

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Number of participants with Adverse event	1day

Secondary

Measure	Time frame	Description
Pharmacokinetic profiles	1day	Blood evaluation variables: Cmax, AUCt (t=24 h), AUC∞, tmax

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026