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Pharmacodynamics and Safety of CDFR0209

NCT02710994 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-03-17

No results posted yet for this study

Summary

This is a randomized, open-label, two-way crossover study to investigate the pharmacodynamics(24 hour gastric pH) and the safety between repeated doses of CDFR0209 and Losec in Healthy Male Volunteers

Conditions

  • Stomach Ulcer
  • Gastroesophageal Reflux

Interventions

DRUG

CDFR0209

Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg

DRUG

Losec

Losec 40 mg

Sponsors & Collaborators

  • CTC Bio, Inc.

    collaborator INDUSTRY

  • Ajou University School of Medicine

    lead OTHER

Principal Investigators

  • Doo-Yeoun Cho, MD · Ajou University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-08-31
Completion
2015-03-31

Countries

  • South Korea

Study Locations

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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 NCT02710994 on ClinicalTrials.gov