A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects
NCT04703868 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2024-01-24
Summary
A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects
Conditions
- Gastroesophageal Reflux Disease
Interventions
- DRUG
-
Rabeprazole Sodium 10mg
Part A: 1 tablet administered before the breakfast during 7 days
- DRUG
-
Rabeprazole Sodium 20mg
Part B: 1 tablet administered before the breakfast during 7 days
Sponsors & Collaborators
-
Seoul National University Hospital
collaborator OTHER -
Yungjin Pharm. Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Seunghwan Lee, M.D., Ph.D · Seoul National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-01-13
- Primary Completion
- 2021-06-01
- Completion
- 2021-06-14
Countries
- South Korea
Study Locations
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