NCT02322671 - Relative Bioavailability Study of Two Montelukast Sodium (GW483100) 5 Milligrams (mg) Chewable Tablets and One Reference Montelukast Sodium 5 mg Chewable Tablet in Healthy Adult Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 23, 2015

Primary Completion Date

April 20, 2015

Study Completion Date

April 20, 2015

Conditions

Respiratory Disorders

Interventions

DRUG

Reference Montelukast

It is available as pink, round, bi-convex-shaped chewable tablet of reference 5 mg montelukast sodium (innovator product). that has to be placed on the tongue and chewed immediately.

DRUG

Test 1 Montelukast

It will be provided as pink, round, bi-convex-shaped chewable tablet of test formulation 1: 5mg montelukast sodium (GW483100) that has to be placed on the tongue and chewed immediately.

DRUG

Test 2 Montelukast

It will be provided as pink, round, bi-convex-shaped chewable tablet of test formulation 2: 5mg montelukast sodium (GW483100) that has to be placed on the tongue and chewed immediately.

Trial Locations (1)

500 013

GSK Investigational Site, Hyderabad