To Evaluate the PK, PD, Safety and Drug Tolerance of JW0302 in Healthy Volunteers

JW Pharmaceutical44 enrolled

Overview

1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions 2. To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Test Drug(JW0302) or Reference Drug(C2206)DRUG

Test Drug: single administration of JW0302 Reference Drug: single administration of C2206 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers Exclusion Criteria: * Subjects does not meet the Inclusion Criteria

Locations (1)

Clinical Trial Center, Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)

Evaluation PK for JW0302 and C2206 after multiple dose

Time frame: up to 24 hours

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

Evaluation PD for ambulatory 24hr pH monitor

Time frame: Baseline versus Multiple dose during 7 days

Data from ClinicalTrials.gov

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