A Study to Compare PK, PD and Safety of CKD-381 and D026 in Healthy Subjects

Phase 1CompletedNCT03558425

Chong Kun Dang Pharmaceutical41 enrolled

Overview

A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

GERD

Interventions

CKD-381DRUG

1 tablet administered before the breakfast during 7 days

D026DRUG

1 tablet administered before the breakfast during 7 days

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: 1. Between 19 aged and 50 aged in healthy male adult 2. Body weight more than 55kg 3. Body Mass Index more than 18.5 and under 25 Exclusion Criteria: 1. Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease. 2. Have a gastrointestinal disease history that can effect drug absorption or surgery. 3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product, additives or benzimidazole family.

Locations (1)

Seoul Nat'l University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

Evaluation PK for Esomeprazole after multiple dose

Time frame: 0~24h

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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