Bioequivalence of GW483100 10 Milligram (mg) Tablets in Healthy Subjects Under Fasting Conditions

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

August 18, 2015

Primary Completion Date

September 21, 2015

Study Completion Date

September 21, 2015

Conditions
Respiratory DisordersAsthma and Rhinitis
Interventions
DRUG

Test Montelukast

Test Montelukast (GW483100) is available as round, biconvex, pink 10 mg film-coated tablet (containing montelukast sodium equivalent to 10 mg of montelukast) and is administered as a single dose with 240 mL of water.

DRUG

Reference Montelukast

Reference Montelukast (innovator product) is available as pale beige, rounded square shaped,10 mg film-coated tablet (containing montelukast sodium equivalent to 10 mg of montelukast) and is administered as a single dose with 240 mL of water. Singular is the innovator product used for this study, which is a trade name owned by Merck Sharp and Dohme Corporation.

Trial Locations (1)

500 013

GSK Investigational Site, Telangana

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02658422 - Bioequivalence of GW483100 10 Milligram (mg) Tablets in Healthy Subjects Under Fasting Conditions | Biotech Hunter | Biotech Hunter