Gastroesophageal Reflux, Stomach Ulcer
Conditions
Keywords
Immediate release omeprazole, Integrated gastric acidity
Brief 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
Detailed description
Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trial Center of Ajou University Medical Center on the 2 day before dosing (Day -2). On Day -1 around 8 AM, ambulatory intragastric pH recording was performed using ZepHr® pH Monitoring System (Sandhill Scientific, Inc., Highlands Ranch, CO, USA) without dosing for 24 hours. On Day 1, subjects was dosed Losec 40 mg or CDFR0209 (Omeprazole 40 mg & sodium bicarbonate 1,100 mg) around 8 AM and ambulatory intragastric pH recording was continued upto 24 hours after dosing. From Day 2 \ 6, subjects were dosed Losec 40 mg or CDFR0209 around 8 AM. On Day 7, subjects was dosed Losec 40 mg or CDFR0209 (Omeprazole 40 mg & sodium bicarbonate 1,100 mg) around 8 AM and ambulatory intragastric pH recording was performed upto 24 hours after dosing. After 14 days of washout period, subjects was dosed Losec 40 mg or CDFR0209 by crossover manner and ambulatory intragastric pH recording was performed.
Interventions
DRUGCDFR0209
Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg
DRUGLosec
Losec 40 mg
Sponsors
CTC Bio, Inc.
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean percent decrease from baseline in integrated gastric acidity after 7th dose | Day 7 upto 24 hours | Data for 24 hour gastric pH were acquired at baseline (day -1) and day 7 of dosing with either Losec 40 mg or CDFR0209. Percent decrease from baseline in integrated gastric acidity after 7th dose = \[Baseline integrated acidity - Day 7 integrated acidity\]/ Baseline integrated acidity × 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean percent decrease from baseline in integrated gastric acidity after 1st dose | Day 1 upto 24 hours | Data for 24 hour gastric pH were acquired at baseline (day -1) and day 1 of dosing with either Losec 40 mg or CDFR0209. Percent decrease from baseline in integrated gastric acidity after 1st dose = \[Baseline integrated acidity - Day 1 integrated acidity\]/ Baseline integrated acidity × 100. |
Other
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Through study completion, an average of 35 days |
Countries
South Korea
Outcome results
None listed