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

A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Compare Pharmaciokinetics, Pharmacodynamics and Safetry After Single/ Multiple Administration of CKD-382 and D026 in Healthy Subjects

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04703374
Enrollment
48
Registered
2021-01-11
Start date
2020-09-25
Completion date
2021-09-30
Last updated
2021-01-11

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

Conditions

GERD

Keywords

CKD-382, D026

Brief summary

To compare pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382 and D026 in healthy subjects

Detailed description

A randomized, open-label, crossover phase 1 clinical trial to compare pharmacokinetics, pharmacodynamics and safety after single / multiple administration of CKD-382 and D026 in healthy subjects

Interventions

DRUGCKD-382(formulation I)

1 tablet administered under fasting condition for 7days

DRUGCKD-382(formulation II)

1 tablet administered under fasting condition for 7days

DRUGD026

1 tablet administered under fasting condition for 7days

Sponsors

Chong Kun Dang Pharmaceutical
Lead SponsorINDUSTRY

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

1. Between 19 aged and 50 aged in healthy adult 2. Body weight more than 50kg 3. Body Mass Index more than 18.0 and under 27.0 4. Who has negative result on Helicobacter Pylori antibody test

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(including surgery) that can effect drug absorption 3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.

Design outcomes

Primary

MeasureTime frame
AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) Evaluation PK after multiple dose0~24h
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose Evaluation PD for ambulatory 24hr pH monitorBaseline versus Multiple dose during 7 days

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