Pharmacodynamics and Safety of CDFR0209

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ajou University School of Medicine
• Collaborator: CTC Bio, Inc.
• Treatments: Omeprazole

Criteria

Inclusion Criteria:

• Healthy male subjects aged 20 - 45 years

• With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9}

• Agreement with written informed consent

Exclusion Criteria:

• Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)

• Inadequate result of laboratory test (especially, AST/ALT > 1.25 x UNL, Total bilirubin > 1.5 x UNL)

• Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test and Helicobacter Ab IgM

• Positive result in urea breath test

• Taking OTC(Over the counter)medicine including oriental medicine within 7 days

• Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)

• Subject with known for hypersensitivity reaction to omeprazole and sodium bicarbonate

• Previous whole blood donation within 60 days or component blood donation within 30 days

• Previous participation of other trial within 90 days

• Continued taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 30 g/day) and severe heavy smoker (cigarette > 1/2 pack per day)

• An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result