Status:
COMPLETED
A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole
Lead Sponsor:
Addpharma Inc.
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 10/600mg to Rabeprazole 10mg in healthy volunteers.
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04494243
Start Date
August 28 2020
End Date
January 15 2021
Last Update
July 21 2021
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea