A Phase 1 interventional study of CDFR0209 and Losec in Stomach Ulcer and Gastroesophageal Reflux, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-17.
Sponsored by Ajou University School of Medicine · Phase 1, Interventional, and Treatment
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
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.
1,066 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 711 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Ajou University School of Medicine is the lead sponsor of 171 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Subjects first received CDFR0209 each morning in a fasting state for 7 days. After a washout period of 14 days, they then received Losec 40 mg in a fasting state each morning for 7 days.
Drug: CDFR0209 · Drug: Losec
Subjects first received Losec 40 mg each morning in a fasting state for 7 days. After a washout period of 14 days, they then received CDFR0209 in a fasting state each morning for 7 days.
Drug: CDFR0209 · Drug: Losec
Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg
Losec 40 mg
Mean percent decrease from baseline in integrated gastric acidity after 7th dose
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.
Time frame: Day 7 upto 24 hours
Mean percent decrease from baseline in integrated gastric acidity after 1st dose
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.
Time frame: Day 1 upto 24 hours
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Through study completion, an average of 35 days
Plan to share: No
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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Ajou University School of Medicine