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

Phase 1Not Yet RecruitingNCT06916130

Addpharma Inc.48 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

AD-120ADRUG

Administered before the breakfast during 7 days, Oral, Tablet

AD-120DRUG

Administered before the breakfast during 7 days, Oral, Tablet

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)

AUCτ,ss after 7days repeated administration of Omeprazole

Time frame: AUCτ,ss: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)

The time of peak concentration after single dose

Tmax after 1days administration of Omeprazole

Time frame: Tmax: from pre-dose to 24 hours of 1st administration

Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring

Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring for 24-hour interval after 7th dose

Time frame: 24 hours before 1st administration to 24 hours after repeated administration (7days)

Central Contacts

Hanna Yang

CONTACT

+82-31-891-6918 hnyang@addpharma.co.kr

Seung Hwan Lee, M.D., Ph.D.

CONTACT

Data from ClinicalTrials.gov

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