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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029313
• Other study ID #: PMK-M01RS1
• Status: Completed
• Phase: Phase 1
• First received: November 3, 2013
• Last updated: April 27, 2015
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2015
• Source: PharmaKing
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Korea Food & Drug Administration
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Asthma and Allergic Rhinitis

Intervention

Drug:
• Montelukast

• Montelukast sodium

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon	Junggu

Sponsors (1)

Lead Sponsor	Collaborator
PharmaKing

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse event		1day	No
Secondary	Pharmacokinetic profiles	Blood evaluation variables: Cmax, AUCt (t=24 h), AUC8, tmax	1day	No