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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Page 1 of 1 (1 locations)

1

Seoul National University Hospital

Seoul, South Korea