Status:
COMPLETED
A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-212-A and AD-2121
Lead Sponsor:
Addpharma Inc.
Conditions:
Gastro Esophageal Reflux
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-212-A in healthy subjects.
Detailed Description
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-212-A compared with AD-2121 in healthy subjects.
Eligibility Criteria
Inclusion
- Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
- Negative result from Serum Helicobacter pylori antibody at the time of screening visit
Exclusion
- Patients with trouble performing Gastric pH monitoring
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06025773
Start Date
September 15 2023
End Date
April 19 2024
Last Update
August 1 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea