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NCT06916130 | NOT YET RECRUITING | Gastroesophageal Reflux Disease (GERD)

A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-120 and AD-120A
Sponsor:

Addpharma Inc.

Brief Summary:

Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects.

Condition or disease

Gastroesophageal Reflux Disease (GERD)

Intervention/treatment

AD-120A

AD-120

Phase

PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 48 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Randomized, Open-label, Multiple Oral-dose, 2x2 Crossover Clinical Trial to Compare the Safety, Pharmacokinetic, and Pharmacodynamic Characteristics of a AD-120 and AD-120A in Healthy Adult Volunteers
Actual Study Start Date : 2025-04-21
Estimated Primary Completion Date : 2025-09-01
Estimated Study Completion Date : 2025-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years to 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * 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 Criteria
  • * Patients with trouble performing pH monitor catheter
A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-120 and AD-120A

Location Details

NCT06916130

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Korea, Republic of,

Seoul National University Hospital

Seoul, Korea, Republic of,