Pharmacodynamics and Safety of CDFR0209

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

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

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux; Stomach Ulcer
• Intervention / Treatment: Drug: CDFR0209; Drug: Losec

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Suwon, Gyeonggi, Korea, Republic of, 443-380
      • Ajou University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Collaborators: CTC Bio, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 12, 2016
• First Posted (Estimate): March 17, 2016

Study Record Updates

• Last Update Posted (Estimate): March 17, 2016
• Last Update Submitted That Met QC Criteria: March 12, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Immediate release omeprazole; Integrated gastric acidity
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Stomach Ulcer
• Other Study ID Numbers: MED-CT1-14-085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No