Status:
COMPLETED
A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects
Lead Sponsor:
Yungjin Pharm. Co., Ltd.
Collaborating Sponsors:
Seoul National University Hospital
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects
Detailed Description
This study is to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects
Eligibility Criteria
Inclusion
- Age 19\~55 years in healthy volunteers
- BMI is more than 18.0 kg/m\^2 , no more than 28.0 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 were judged ineligible by the investigator
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2021
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04703868
Start Date
January 13 2021
End Date
June 14 2021
Last Update
January 24 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Daehak-ro Jongno-gu, South Korea, 110-744