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

Asthma and Allergic Rhinitis Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma and Allergic Rhinitis

• NCT number: NCT02029313
• Study type: Interventional
• Source: PharmaKing
• Status: Completed
• Phase: Phase 1
• Start date: November 2013
• Completion date: March 2014