Clinical Trials Logo
  1. Home
  2. Gastritis
  3. 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

Gastritis Clinical Trial

Official title:
An Open-label, Randomised, Single Dose, Three-Way Crossover, Six Sequence, 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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02201316
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date February 3, 2014
Completion date March 18, 2014
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04289519 - Endoscopic Findings of Gastritis in Children
Recruiting NCT02353039 - Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis Phase 2
Recruiting NCT05545397 - Sedation Level on Machine Learning With Electroencephalogram in Painless Gastroenteroscopy Patients
Not yet recruiting NCT05510388 - HFNO Reduces Hypoxia During Sedated Gastroscopy or Colonoscopy in High Risk Patients N/A
Completed NCT02724280 - Linked Color Imaging to Differentiate H. Pylori Associated Gastritis and Gastric Atrophy N/A
Not yet recruiting NCT02961296 - Helicobacter Pylori Antibiotic Susceptibility Testing of Korea N/A
Completed NCT02385045 - i-Scan for the Detection of Helicobacter Pylori N/A
Completed NCT00212225 - Risk Factors for Gastric Disease in Pediatric Helicobacter Pylori (H. Pylori) N/A
Completed NCT04672018 - Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis Phase 2
Not yet recruiting NCT05072938 - Phase IV Clinical Trial to Compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis Phase 4
Completed NCT02597517 - New Technology to Differentiate Normal Gastric Mucosa From Helicobacter Pylori Associated Gastritis and Gastric Atrophy N/A
Completed NCT02296021 - Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Bismuth-containing Quadruple Therapy Phase 4
Completed NCT01576289 - Analysis of Biopsies From the Upper Gastrointestinal Tract N/A
Active, not recruiting NCT03509831 - [KJ-INT-002] BE Study Phase 1
Terminated NCT05579444 - Systems Biology of Gastrointestinal and Related Diseases
Suspended NCT04306939 - Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
Completed NCT05237115 - Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy Phase 4
Completed NCT02393430 - Clinical Effect of Rebamipide on Chronic Gastritis Phase 4
Completed NCT00579410 - Comparison of Acid Reflux at Two Levels in the Esophagus Using the BRAVO Capsule N/A
Completed NCT00267475 - Data Bank for Eosinophilic Disorders N/A