A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects

Yungjin Pharm. Co., Ltd.88 enrolled

Overview

A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects

This study is to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux Disease

Interventions

Rabeprazole Sodium 10mgDRUG

Part A: 1 tablet administered before the breakfast during 7 days

Rabeprazole Sodium 20mgDRUG

Part B: 1 tablet administered before the breakfast during 7 days

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 19\~55 years in healthy volunteers * BMI is more than 18.0 kg/m\^2 , no more than 28.0 kg/m\^2 * Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing Exclusion Criteria: * Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system * Subjects who were judged ineligible by the investigator

Locations (1)

Seoul National University Hospital

Seoul, Daehak-ro Jongno-gu, South Korea

Outcomes

Primary Outcomes

Integrated gastric acidity

Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 7th dose

Time frame: From Day 1 up to Day 28

AUCt,ss

Evaluateion PK Rabeprazole after multiple dose

Time frame: From Day 1 up to Day 29

Secondary Outcomes

Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 1 st dose

Evaluateion PD Rabeprazole after multiple dose

Time frame: 24 hours

Percent of time with gastric pH>4 for 24 hour interval after 1st and 7th dose

Evaluateion PD Rabeprazole after multiple dose

Time frame: From Day 1 up to Day 28

Mean and median gastric pH after 1st and 7th dose

Evaluateion PD Rabeprazole after multiple dose

Time frame: From Day 1 up to Day 28

AUCτ

Evaluateion PK Rabeprazole after multiple dose

Time frame: From Day 1 up to Day 29

Cmax

Evaluateion PK Rabeprazole after multiple dose

Time frame: From Day 1 up to Day 29

Tmax

Evaluateion PK Rabeprazole after multiple dose

Time frame: From Day 1 up to Day 29

t1/2

Data from ClinicalTrials.gov

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