A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole
A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-214-02 to Rabeprazole in Healthy Volunteers
1 other identifier
interventional
43
1 country
1
Brief Summary
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214-02 to Rabeprazole in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2020
CompletedFirst Posted
Study publicly available on registry
November 10, 2020
CompletedStudy Start
First participant enrolled
December 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2021
CompletedJuly 21, 2021
July 1, 2021
3 months
November 4, 2020
July 20, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
AUCtau,ss(Area under the plasma drug concentration-time curve)
Evaluation PK Rabeprazole after multiple dose
From Day 1 up to Day 29
Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)
Evaluation PD Rabeprazole after multiple dose
Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring
Secondary Outcomes (9)
AUCtau(Area under the plasma drug concentration-time curve)
Day1
Cmax(Maximum concentration of drug in plasma)
Day1
Tmax(Time to maximum plasma concentration)
Day1
t1/2(Terminal elimination half-life)
Day1
Cmax,ss(Maximum concentration of drug in plasma at steady state)
From Day 1 up to Day 29
- +4 more secondary outcomes
Study Arms (2)
AD-214-02/Rabeprazole
EXPERIMENTALPeriod 1 : Test Drug(AD-214-02) Period 2 : Reference Drug(Rabeprazole)
Rabeprazole/AD-214
EXPERIMENTALPeriod 1 : Reference Drug(Rabeprazole) Period 2 : Test Drug(AD-214-02)
Interventions
1 tablet administered before the breakfast during 7 days
1 tablet administered before the breakfast during 7 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Addpharma Inc.lead
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seunghwan Lee, M.D.,Ph.D
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2020
First Posted
November 10, 2020
Study Start
December 5, 2020
Primary Completion
March 8, 2021
Study Completion
March 8, 2021
Last Updated
July 21, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share