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

Addpharma Inc.24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastro Esophageal Reflux

Interventions

Lansoprazole 15 mgDRUG

AD-2121 (Lansoprazole 15 mg), Oral, Capsule

Lansoprazole 15mg/Calcium carbonate 600mgDRUG

AD-212-A (Lansoprazole 15mg/Calcium carbonate 600mg), Oral, Tablet

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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 Lansoprazole

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

Percent Decrease from baseline of Integrated gastric acidity

Percent Decrease from baseline of Integrated gastric acidity after repeated adadministration of Lansoprazole Integrated gastric acidity calculation: (Integrated gastric acidity Before - Integrated gastric acidity after)/Integrated gastric acidity Before\*100 * Acid concentration (mM) = 1000 ⅹ 10-pH * Acidity (mmol.h/L) = (acid in mM at time 't' + acid in mM at time 't-1')/2 ⅹ (t-(t-1)) * Integrated Acidity means cumulative sum per second for 24 hours

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

Data from ClinicalTrials.gov

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