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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03444402
Enrollment
18
Registered
2018-02-23
Start date
2018-03-02
Completion date
2018-05-04
Last updated
2018-05-24

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

Conditions

GERD

Keywords

CKD-381, Nexium

Brief summary

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

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

Interventions

DRUGCKD-381(formulation I)

1 tablet administered before the breakfast during 7 days

DRUGCKD-381(formulation II)

1 tablet administered before the breakfast during 7 days

DRUGD026(Nexium 40mg)

1 tablet administered before the breakfast during 7 days

Sponsors

Chong Kun Dang Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

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 Esomeprazole, additives or benzimidazole family.

Design outcomes

Primary

MeasureTime frameDescription
AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state)0~24hEvaluation PK esomeprazole after multiple dose

Secondary

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

Countries

South Korea

Outcome results

None listed

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