MedTrace Logo

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

NCT02201316 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-05-15

No results posted yet for this study

Summary

This study aims to determine the relative bioavailability of two candidate formulations of mosapride citrate 5mg tablets compared the reference product GASMOTIN (mosapride citrate 5mg) from Dainippon Pharmaceutical Company in healthy adult subjects. This will be an open-label, randomised, single dose, three-way crossover, six sequence study. Subjects will receive a single oral dose separated by at least 7 days and no greater than 14 days washout period. This study is required to select a candidate mosapride citrate (GR107719B) formulation for further development and provide data to allow the design of a future pivotal bioequivalence study. The candidate formulations will be compared with the innovator GASMOTIN. GASMOTIN is a trademark of Dainippon Sumitomo Pharmaceutical Company.

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-03
Primary Completion
2014-03-18
Completion
2014-03-18

Countries

  • India

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02201316 on ClinicalTrials.gov