Pharmacodynamics and Safety of CDFR0209

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Open Label, Two-way Crossover Designed Clinical Trial to Investigate the Pharmacodynamics and the Safety Between Repeated Doses of CDFR0209 in Healthy Male Volunteers

Conditions
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Stomach Ulcer, Gastroesophageal Reflux

Intervention / Treatment
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* Drug: CDFR0209
* Drug: Losec


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDFR0209, Then Losec<br>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<br>* Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg<br>Drug: Losec<br>* Losec 40 mg<br>|
| Experimental: Losec, Then CDFR0209<br>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<br>* Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg<br>Drug: Losec<br>* Losec 40 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 7 upto 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 upto 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immediate release omeprazole, Integrated gastric acidity