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

Addpharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Drug: AD-120; Drug: AD-120A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06916130

AD-120PK/PD

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Arm-A

Experimental group

Description:

Period 1 : Test Drug (AD-120), Period 2 : Reference Drug (AD-120A)

Treatment:

Drug: AD-120A

Drug: AD-120

Arm-B

Experimental group

Description:

Period 1 : Reference Drug (AD-120A), Period 2 : Test Drug (AD-120)

Treatment:

Drug: AD-120A

Drug: AD-120