Back to resultsA Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-214-02
Rabeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease
Eligibility Criteria
Inclusion Criteria:
- Age 19~50 years in healthy volunteers
- BMI is more than 18.0 kg/m^2 , no more than 27.0 kg/m^2
- Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Exclusion Criteria:
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Subjects who judged ineligible by the investigator
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AD-214-02/Rabeprazole
Rabeprazole/AD-214
Arm Description
Period 1 : Test Drug(AD-214-02) Period 2 : Reference Drug(Rabeprazole)
Period 1 : Reference Drug(Rabeprazole) Period 2 : Test Drug(AD-214-02)
Outcomes
Primary Outcome Measures
AUCtau,ss(Area under the plasma drug concentration-time curve)
Evaluation PK Rabeprazole after multiple dose
Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)
Evaluation PD Rabeprazole after multiple dose
Secondary Outcome Measures
AUCtau(Area under the plasma drug concentration-time curve)
Evaluation PK Rabeprazole after single dose
Cmax(Maximum concentration of drug in plasma)
Evaluation PK Rabeprazole after single dose
Tmax(Time to maximum plasma concentration)
Evaluation PK Rabeprazole after single dose
t1/2(Terminal elimination half-life)
Evaluation PK Rabeprazole after single dose
Cmax,ss(Maximum concentration of drug in plasma at steady state)
Evaluation PK Rabeprazole after multiple dose
Tmax,ss(Time to maximum plasma concentration at steady state)
Evaluation PK Rabeprazole after multiple dose
t1/2,ss(Terminal elimination half-life at steady state)
Evaluation PK Rabeprazole after multiple dose
After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours
Evaluation PD Rabeoprazoke
After the first administration and 7 days of repeated administration, The median pH measured for 24 hours
Evaluation PD Rabeoprazoke
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04622358
Brief Title
A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole
Official Title
A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-214-02 to Rabeprazole in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 5, 2020 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
March 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addpharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214-02 to Rabeprazole in healthy volunteers.
Detailed Description
This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214-02 compared with administration of Rabeprazole in healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AD-214-02/Rabeprazole
Arm Type
Experimental
Arm Description
Period 1 : Test Drug(AD-214-02) Period 2 : Reference Drug(Rabeprazole)
Arm Title
Rabeprazole/AD-214
Arm Type
Experimental
Arm Description
Period 1 : Reference Drug(Rabeprazole) Period 2 : Test Drug(AD-214-02)
Intervention Type
Drug
Intervention Name(s)
AD-214-02
Intervention Description
1 tablet administered before the breakfast during 7 days
Intervention Type
Drug
Intervention Name(s)
Rabeprazole
Intervention Description
1 tablet administered before the breakfast during 7 days
Primary Outcome Measure Information:
Title
AUCtau,ss(Area under the plasma drug concentration-time curve)
Description
Evaluation PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)
Description
Evaluation PD Rabeprazole after multiple dose
Time Frame
Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
Secondary Outcome Measure Information:
Title
AUCtau(Area under the plasma drug concentration-time curve)
Description
Evaluation PK Rabeprazole after single dose
Time Frame
Day1
Title
Cmax(Maximum concentration of drug in plasma)
Description
Evaluation PK Rabeprazole after single dose
Time Frame
Day1
Title
Tmax(Time to maximum plasma concentration)
Description
Evaluation PK Rabeprazole after single dose
Time Frame
Day1
Title
t1/2(Terminal elimination half-life)
Description
Evaluation PK Rabeprazole after single dose
Time Frame
Day1
Title
Cmax,ss(Maximum concentration of drug in plasma at steady state)
Description
Evaluation PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
Tmax,ss(Time to maximum plasma concentration at steady state)
Description
Evaluation PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
t1/2,ss(Terminal elimination half-life at steady state)
Description
Evaluation PK Rabeprazole after multiple dose
Time Frame
From Day 1 up to Day 29
Title
After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours
Description
Evaluation PD Rabeoprazoke
Time Frame
Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
Title
After the first administration and 7 days of repeated administration, The median pH measured for 24 hours
Description
Evaluation PD Rabeoprazoke
Time Frame
Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 19~50 years in healthy volunteers
BMI is more than 18.0 kg/m^2 , no more than 27.0 kg/m^2
Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Exclusion Criteria:
Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
Subjects who judged ineligible by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seunghwan Lee, M.D.,Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole
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