A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-212-A and AD-2121

Addpharma

Status and phase: Completed; Phase 1

Conditions: Gastro Esophageal Reflux

Treatments: Drug: Lansoprazole 15mg/Calcium carbonate 600mg; Drug: Lansoprazole 15 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06025773

AD-212PK/PD-03

Details and patient eligibility

About

Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-212-A in healthy subjects.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• Patients with trouble performing Gastric pH monitoring

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Arm-A

Experimental group

Description:

Period 1 : Reference Drug (AD-2121), Period 2 : Test Drug (AD-212-A)

Treatment:

Drug: Lansoprazole 15 mg

Drug: Lansoprazole 15mg/Calcium carbonate 600mg

Arm-B

Experimental group

Description:

Period 1 : Test Drug (AD-212-A), Period 2 : Reference Drug (AD-2121)

Treatment:

Drug: Lansoprazole 15 mg

Drug: Lansoprazole 15mg/Calcium carbonate 600mg