A Study to Evaluate the PK, PD and Safety of CKD-382 in Healthy Subjects

A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety After Single/Multiple Administration of CKD-382, D860 and D027 in Healthy Subjects

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05108038

Enrollment

Registered

2021-11-04

Start date

2021-10-07

Completion date

2022-02-28

Last updated

2021-11-04

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

Conditions

GERD

Keywords

CKD-382, D860, D027

Brief summary

to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

Detailed description

A randomized, open-label, crossover phase 1 clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

Interventions

DRUGCKD-382, D860, D027

QD, PO for 7days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Between 19 aged and 50 aged in healthy adult * Body weight more than 50kg * BMI more than 18.0 and under 27.0 * Who has negative result on Helicobacter Pylori antibody test

Exclusion criteria

* 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 * Have a gastrointestinal disease history(including surgery) that can effect drug absorption * Hypersensitivity reaction of clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family

Design outcomes

Primary

Measure	Time frame	Description
Primary Pharmacokinetic Endpoint	0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours	AUCt,ss Evaluation after multiple dose -AUCt,ss: Area under the plasma drug concentration-time curve within a dosing interval in steady-state
Primary Pharmacodynamic Endpoint	24 hours after multiple dose for 7 days compared to baseline	Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose

Secondary

Measure	Time frame	Description
(1) Secondary Pharmacokinetic Endpoint	0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours	Cmax,ss Evaluation after multiple dose -Cmax,ss: Maximum concentration of drug in plasma
(2) Secondary Pharmacokinetic Endpoint	0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours	Cmax Evaluation after single dose -Cmax: Maximum concentration of drug in plasma
(1) Secondary Pharmacodynamic Endpoint	24 hours after first dose compared to baseline	Percent decrease from baseline in integrated gastric acidity for 24-hour interval after first dose
(2) Secondary Pharmacodynamic Endpoint	24 hours after first dose and multiple dose for 7 days	Percent of time with gastric pH≤4 for 24-hour interval after first or 7th dose

Countries

South Korea

Contacts

Primary ContactMinkyu Park, Ph.D

mk_park@cbnuhctc.com043-269-8708

Outcome results

None listed

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