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

A Randomized, Open-label, Multiple-dose, and Three-way Crossover Clinical Trial to Compare Pharmacokinetics and Safety of CKD-381 and D026 in Healthy Male Subjects

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

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Drug: CKD-381(formulation I); Drug: CKD-381(formulation II); Drug: D026(Nexium 40mg)

Detailed Description

A randomized, open-label, multiple-dose, and three-way cross over clinical trial to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul 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 Esomeprazole, additives or benzimidazole family.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026)	Drug: CKD-381(formulation I); 1 tablet administered before the breakfast during 7 days; Drug: CKD-381(formulation II); 1 tablet administered before the breakfast during 7 days; Drug: D026(Nexium 40mg); 1 tablet administered before the breakfast during 7 days
EXPERIMENTAL: Group B; Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I)	Drug: CKD-381(formulation I); 1 tablet administered before the breakfast during 7 days; Drug: CKD-381(formulation II); 1 tablet administered before the breakfast during 7 days; Drug: D026(Nexium 40mg); 1 tablet administered before the breakfast during 7 days
EXPERIMENTAL: Group C; Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II)	Drug: CKD-381(formulation I); 1 tablet administered before the breakfast during 7 days; Drug: CKD-381(formulation II); 1 tablet administered before the breakfast during 7 days; Drug: D026(Nexium 40mg); 1 tablet administered before the breakfast during 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state)	Evaluation PK esomeprazole after multiple dose	0~24h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,ss(Maximum concentration of drug in plasma at steady state)	Evaluation PK esomeprazole after multiple dose	0~24h
Tmax,ss(Time to maximum plasma concentration at steady state)	Evaluation PK esomeprazole after multiple dose	0~24h
t1/2(Terminal elimination half-life)	Evaluation PK esomeprazole after multiple dose	0~24h
R(Accumulation ratio)	Evaluation PK esomeprazole after multiple dose	0~24h
CLss/F(Apparent Clearance at steady state)	Evaluation PK esomeprazole after multiple dose	0~24h
Vss/F(Apparent Volume of distribution at steady state)	Evaluation PK esomeprazole after multiple dose	0~24h
Cmax(Maximum concentration of drug in plasma)	Evaluation PK esomeprazole after single dose	0~24h
AUClast(Area under the plasma drug concentration-time curve from 0 to last)	Evaluation PK esomeprazole after single dose	0~24h
Tmax(Time to maximum plasma concentration)	Evaluation PK esomeprazole after single dose	0~24h
t1/2(Terminal elimination half-life)	Evaluation PK esomeprazole after single dose	0~24h
CL/F(Apparent clearance)	Evaluation PK esomeprazole after single dose	0~24h
Vd/F(Apparent volume of distribution)	Evaluation PK esomeprazole after single dose	0~24h

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2018
• Primary Completion (ACTUAL): May 4, 2018
• Study Completion (ACTUAL): May 4, 2018

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (ACTUAL): February 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Nexium; CKD-381
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: 173HPS17013

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