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

A Randomized, Open-label, Multiple-dose, and Crossover Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of CKD-381 and D026 in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Drug: D026; Drug: CKD-381

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul Nat'l University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TR group; Period 1: Test drug(CKD-381) Period 2: Reference drug(D026)	Drug: D026; 1 tablet administered before the breakfast during 7 days
Experimental: RT group; Period 1: Reference drug(D026) Period 2: Test drug(CKD-381)	Drug: CKD-381; 1 tablet administered before the breakfast during 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose	Evaluation PD for ambulatory 24hr pH monitor	Baseline versus Multiple dose during 7 days
AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state)	Evaluation PK for Esomeprazole after multiple dose	0~24h

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Kyung Sang Yu, M.D., Ph.D., Department of Clinical Pharmacology and Therapeutics, Seoul Nat'l University College of Medicine and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2018
• Primary Completion (Actual): September 14, 2018
• Study Completion (Actual): September 14, 2018

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: CKD-381; D026
• Other Study ID Numbers: 173BE18010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No