- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04494243
A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole
July 20, 2021 updated by: Addpharma Inc.
A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-214 10/600mg to Rabeprazole 10mg in Healthy Volunteers
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 10/600mg to Rabeprazole 10mg in healthy volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214 10/600mg compared with administration of Rabeprazole 10mg in healthy volunteers.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AD-214/Rabeprazole
Period 1 : Test Drug(AD-214 10/600mg) Period 2 : Reference Drug(Rabeprazole 10mg)
|
1 tablet administered before the breakfast during 7 days
Other Names:
1 tablet administered before the breakfast during 7 days
Other Names:
|
Experimental: Rabeprazole/AD-214
Period 1 : Reference Drug(Rabeprazole 10mg) Period 2 : Test Drug(AD-214 10/600mg)
|
1 tablet administered before the breakfast during 7 days
Other Names:
1 tablet administered before the breakfast during 7 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)
Time Frame: Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
|
Evaluation PD Rabeprazole after multiple dose
|
Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
|
AUCtau,ss(Area under the plasma drug concentration-time curve)
Time Frame: From Day 1 up to Day 29
|
Evaluateion PK Rabeprazole after multiple dose
|
From Day 1 up to Day 29
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCtau(Area under the plasma drug concentration-time curve)
Time Frame: Day1
|
Evaluation PK Rabeprazole after single dose
|
Day1
|
Cmax(Maximum concentration of drug in plasma)
Time Frame: Day1
|
Evaluation PK Rabeprazole after single dose
|
Day1
|
Tmax(Time to maximum plasma concentration)
Time Frame: Day1
|
Evaluation PK Rabeprazole after single dose
|
Day1
|
t1/2(Terminal elimination half-life)
Time Frame: Day1
|
Evaluation PK Rabeprazole after single dose
|
Day1
|
Cmax,ss(Maximum concentration of drug in plasma at steady state)
Time Frame: From Day 1 up to Day 29
|
Evaluation PK Rabeprazole after multiple dose
|
From Day 1 up to Day 29
|
Tmax,ss(Time to maximum plasma concentration at steady state)
Time Frame: From Day 1 up to Day 29
|
Evaluation PK Rabeprazole after multiple dose
|
From Day 1 up to Day 29
|
t1/2,ss(Terminal elimination half-life at steady state)
Time Frame: From Day 1 up to Day 29
|
Evaluation PK Rabeprazole after multiple dose
|
From Day 1 up to Day 29
|
After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours
Time Frame: Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
|
Evaluation PD Rabeoprazoke
|
Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
|
After the first administration and 7 days of repeated administration, The median pH measured for 24 hours
Time Frame: Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
|
Evaluation PD Rabeoprazoke
|
Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
|
CL/F(Apparent clearance)
Time Frame: Day1
|
Evaluation PK Rabeprazole after single dose
|
Day1
|
Vd/F(Apparent volume of distribution)
Time Frame: Day1
|
Evaluation PK Rabeprazole after single dose
|
Day1
|
Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma)
Time Frame: From Day 1 up to Day 29
|
Evaluation PK Rabeprazole after multiple dose
|
From Day 1 up to Day 29
|
Cav,ss(Average concentration of drug in plasma at steady state)
Time Frame: From Day 1 up to Day 29
|
Evaluation PK Rabeprazole after multiple dose
|
From Day 1 up to Day 29
|
CLss/F(Apparent Clearance at steady state)
Time Frame: From Day 1 up to Day 29
|
Evaluation PK Rabeprazole after multiple dose
|
From Day 1 up to Day 29
|
Vss/F(Apparent Volume of distribution at steady state)
Time Frame: From Day 1 up to Day 29
|
Evaluation PK Rabeprazole after multiple dose
|
From Day 1 up to Day 29
|
PTF(Peak trough fluctuation over one dosing interal at steady state)
Time Frame: From Day 1 up to Day 29
|
Evaluation PK Rabeprazole after multiple dose
|
From Day 1 up to Day 29
|
After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours
Time Frame: Day1 24hours monitoring
|
Evaluation PD Rabeoprazoke
|
Day1 24hours monitoring
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seunghwan Lee, M.D.,Ph.D, Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2020
Primary Completion (Actual)
January 15, 2021
Study Completion (Actual)
January 15, 2021
Study Registration Dates
First Submitted
July 30, 2020
First Submitted That Met QC Criteria
July 30, 2020
First Posted (Actual)
July 31, 2020
Study Record Updates
Last Update Posted (Actual)
July 21, 2021
Last Update Submitted That Met QC Criteria
July 20, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AD-214PK/PD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastroesophageal Reflux Disease
-
TakedaTerminatedGastroesophageal Reflux Disease | Non-erosive Reflux DiseaseSwitzerland, Netherlands
-
Vanderbilt University Medical CenterCompletedGastroesophageal Reflux Disease (GERD) | Non-erosive Reflux Disease (NERD)United States
-
Mansoura UniversityWithdrawnGastroesophageal Reflux Disease
-
Cliniques universitaires Saint-Luc- Université...UnknownGastroesophageal Reflux DiseaseBelgium
-
GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
-
King Chulalongkorn Memorial HospitalCompleted
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedGastroesophageal Reflux Disease | GERD | Acid Reflux | RefluxUnited States
-
PfizerTerminatedGastroesophageal Reflux DiseaseBrazil, Germany, Korea, Republic of, Belgium, Spain, Slovakia, France
-
GlaxoSmithKlineCompletedReflux, Gastroesophageal | Gastroesophageal Reflux DiseaseAustralia
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedGastroesophageal Reflux Disease (GERD) | RefluxUnited States, Canada
Clinical Trials on AD-214 10/600mg
-
AdAlta LimitedCompletedChronic Kidney Diseases | Interstitial Lung DiseaseAustralia
-
AdAlta LimitedCompletedInterstitial Lung DiseaseAustralia
-
Addpharma Inc.CompletedGastroesophageal Reflux DiseaseKorea, Republic of
-
Addpharma Inc.CompletedHypertension | HyperlipidemiasKorea, Republic of
-
Addpharma Inc.CompletedHypertension | HyperlipidemiasKorea, Republic of
-
Crucell Holland BVThe PATH Malaria Vaccine Initiative (MVI); Seattle Children's Research Institute...Completed
-
Addpharma Inc.CompletedGastroesophageal Reflux DiseaseKorea, Republic of
-
Kang Stem Biotech Co., Ltd.RecruitingSafety and Efficacy of FURESTEM-AD Inj. for Moderate to Severe Atopic Dermatitis (AD) (smart(FURIN))Dermatitis, AtopicKorea, Republic of
-
Merck Sharp & Dohme LLCHIV Vaccine Trials NetworkTerminatedHIV Infections | AIDS
-
Juul Labs, Inc.CompletedTobacco Use | Tobacco Smoking | Nicotine Dependence | Nicotine Dependence, CigarettesNew Zealand