CompletedNCT03444402Updated May 24, 2018

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

A Phase 1 interventional study of CKD-381(formulation I) and CKD-381(formulation II) in GERD, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-24.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 18
Allocation: Randomized
Ages: 19 Years to 50 Years
Sex: Male

Study summary

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

Read the 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

Conditions studied

GERD

Keywords

CKD-381
Nexium

Who can participate

Ages eligible: 19 Years to 50 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

Between 19 aged and 50 aged in healthy male adult
Body weight more than 55kg
Body Mass Index more than 18.5 and under 25

Exclusion criteria

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 18 participants (actual)

Study arms

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) · Drug: CKD-381(formulation II) · Drug: D026(Nexium 40mg)
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) · Drug: CKD-381(formulation II) · Drug: D026(Nexium 40mg)
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) · Drug: CKD-381(formulation II) · Drug: D026(Nexium 40mg)

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Seoul University Hospital
Seoul, Korea, Republic of

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03444402
Lead sponsor: Chong Kun Dang Pharmaceutical
Responsible party: Sponsor
First posted: Feb 23, 2018
Start date: Mar 2, 2018
Primary completion: May 4, 2018
Completion: May 4, 2018
Last update: May 24, 2018

Study contacts

Kyung Sang Yu, M.D

principal investigator · Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Chong Kun Dang Pharmaceutical

Start the discussion