NCT02029313

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

November 3, 2013

Last Update Submit

April 27, 2015

Conditions

Asthma and Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Adverse event

    1day

Secondary Outcomes (1)

  • Pharmacokinetic profiles

    1day

Study Arms (2)

MKT-N2

EXPERIMENTAL

Montelukast

Drug: MontelukastDrug: Montelukast sodium

Singulair

ACTIVE COMPARATOR

Montelukast sodium

Drug: MontelukastDrug: Montelukast sodium

Interventions

MontelukastDRUG
MKT-N2Singulair
Montelukast sodiumDRUG
MKT-N2Singulair

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Korean Male over20, under 45 years old
  • kg over weight, IBW +-20% range male

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inha University Hospital

Incheon, Junggu, South Korea

Location

MeSH Terms

Conditions

AsthmaRhinitis, Allergic

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2013

First Posted

January 7, 2014

Study Start

November 1, 2013

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations

KR(1)