Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacodynamics and Safety of CDFR0209

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02710994
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : March 17, 2016
Sponsor:
Collaborator:
CTC Bio, Inc.
Information provided by (Responsible Party):
Doo-Yeoun Cho, Ajou University School of Medicine

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

Condition or disease Intervention/treatment Phase
Stomach Ulcer Gastroesophageal Reflux Drug: CDFR0209 Drug: Losec Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn

Arm Intervention/treatment
Experimental: CDFR0209, Then Losec
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
Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg

Drug: Losec
Losec 40 mg

Experimental: Losec, Then CDFR0209
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
Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg

Drug: Losec
Losec 40 mg




Primary Outcome Measures :
  1. Mean percent decrease from baseline in integrated gastric acidity after 7th dose [ Time Frame: 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 Outcome Measures :
  1. Mean percent decrease from baseline in integrated gastric acidity after 1st dose [ Time Frame: 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 Outcome Measures:
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Through study completion, an average of 35 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710994


Locations
Layout table for location information
Korea, Republic of
Ajou University Medical Center
Suwon, Gyeonggi, Korea, Republic of, 443-380
Sponsors and Collaborators
Ajou University School of Medicine
CTC Bio, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Doo-Yeoun Cho, MD Ajou University School of Medicine
Layout table for additonal information
Responsible Party: Doo-Yeoun Cho, Assistant Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02710994    
Other Study ID Numbers: MED-CT1-14-085
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Doo-Yeoun Cho, Ajou University School of Medicine:
Immediate release omeprazole
Integrated gastric acidity
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Stomach Ulcer
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases