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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03558425

Enrollment

Registered

2018-06-15

Start date

2018-06-27

Completion date

2018-09-14

Last updated

2018-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD

Keywords

CKD-381, D026

Brief summary

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

Interventions

DRUGCKD-381

1 tablet administered before the breakfast during 7 days

DRUGD026

1 tablet administered before the breakfast during 7 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026