Status:
NOT_YET_RECRUITING
A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-120 and AD-120A
Lead Sponsor:
Addpharma Inc.
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects.
Detailed Description
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-120 compared with AD-120A in healthy subjects.
Eligibility Criteria
Inclusion
- Body weight equal to or greater than 50.0kg and equal to or less than 90.0kg and Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 and equal to or less than 50 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 pH monitor catheter
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06916130
Start Date
April 21 2025
End Date
September 1 2025
Last Update
April 8 2025
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea