A Pilot Study to Determine the Relative Bioavailability of Mosapride 5mg From Two Candidate Formulations of GR107719B Relative to One 5mg Tablet of Reference Mosapride Citrate (GASMOTIN™) in Healthy Adult Human Subjects Under Fasting Conditions

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

February 3, 2014

Primary Completion Date

March 18, 2014

Study Completion Date

March 18, 2014

Conditions
Gastritis
Interventions
DRUG

Reference mosapride citrate (GASMOTIN)

Reference mosapride citrate (GASMOTIN) 5mg will be supplied as caplet shaped tablet embossed with P218 and film-coated; administer orally with approximately 240 mL of water.

DRUG

GR107719B (Formulation 1)

GR107719B (Formulation 1) 5 mg will be supplied as L-HPC disintegrant caplet shaped tablet, embossed and film-coated; administer orally with approximately 240 mL of water.

DRUG

GR107719B (Formulation 2)

GR107719B (Formulation 2) 5 mg will be supplied as caplet shaped tablet, embossed and film-coated; administer orally with approximately 240 mL of water.

Trial Locations (1)

500 013

GSK Investigational Site, Hyderabad

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02201316 - A Pilot Study to Determine the Relative Bioavailability of Mosapride 5mg From Two Candidate Formulations of GR107719B Relative to One 5mg Tablet of Reference Mosapride Citrate (GASMOTIN™) in Healthy Adult Human Subjects Under Fasting Conditions | Biotech Hunter | Biotech Hunter