Back to resultsPharmacodynamics and Safety of CDFR0209
Primary Purpose
Stomach Ulcer, Gastroesophageal Reflux
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CDFR0209
Losec
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Ulcer focused on measuring Immediate release omeprazole, Integrated gastric acidity
Eligibility 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
Sites / Locations
- Ajou University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CDFR0209, Then Losec
Losec, Then CDFR0209
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02710994
First Posted
March 4, 2016
Last Updated
March 12, 2016
Sponsor
Ajou University School of Medicine
Collaborators
CTC Bio, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02710994
Brief Title
Pharmacodynamics and Safety of CDFR0209
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
Collaborators
CTC Bio, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Ulcer, Gastroesophageal Reflux
Keywords
Immediate release omeprazole, Integrated gastric acidity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CDFR0209, Then Losec
Arm Type
Experimental
Arm Description
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.
Arm Title
Losec, Then CDFR0209
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CDFR0209
Intervention Description
Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg
Intervention Type
Drug
Intervention Name(s)
Losec
Intervention Description
Losec 40 mg
Primary Outcome Measure Information:
Title
Mean percent decrease from baseline in integrated gastric acidity after 7th dose
Description
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
Secondary Outcome Measure Information:
Title
Mean percent decrease from baseline in integrated gastric acidity after 1st dose
Description
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
Other Pre-specified Outcome Measures:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
Through study completion, an average of 35 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doo-Yeoun Cho, MD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Medical Center
City
Suwon
State/Province
Gyeonggi
ZIP/Postal Code
443-380
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Pharmacodynamics and Safety of CDFR0209
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