GERDPhase 1NCT03444402

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

A Phase 1 study testing CKD-381(formulation I), CKD-381(formulation II) and D026(Nexium 40mg) in people with GERD, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects Read more about this study

Who is it for?: Ages 19 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: GERD
What is being tested?: CKD-381(formulation I), CKD-381(formulation II) and D026(Nexium 40mg)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteSouth Korea
Study dates: 2 Mar 2018to 4 May 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul University Hospital
Seoul

Other trials in South Korea

About this study

Official title: 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

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: GERD
Being tested: CKD-381(formulation I), CKD-381(formulation II), D026(Nexium 40mg)
Keywords: CKD-381, Nexium
Medical subject headings: Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CKD-381(formulation I)Drug
1 tablet administered before the breakfast during 7 days
CKD-381(formulation II)Drug
1 tablet administered before the breakfast during 7 days
D026(Nexium 40mg)Drug
1 tablet administered before the breakfast during 7 days

Study groups in NCT03444402
Study group	Role	What they receive
Group A	Experimental	Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026) Receives: Drug: CKD-381(formulation I); Drug: CKD-381(formulation II); Drug: D026(Nexium 40mg)
Group B	Experimental	Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I) Receives: Drug: CKD-381(formulation I); Drug: CKD-381(formulation II); Drug: D026(Nexium 40mg)
Group C	Experimental	Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II) Receives: Drug: CKD-381(formulation I); Drug: CKD-381(formulation II); Drug: D026(Nexium 40mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (12)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 20184 May 2018

First posted23 Feb 2018
Study start2 Mar 2018
Primary completion4 May 2018
Study completion4 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GERDStudies of the same condition, open and under way.
More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03444402
Sponsor's protocol ID: 173HPS17013
Status last verified: May 2018
First submitted: 6 Feb 2018
Last updated: 24 May 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

All GERD trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03444402
Acronym / sponsor ID: 173HPS17013
Conditions: GERD
Keywords: CKD-381, Nexium
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 2 Mar 2018 (actual)
Primary completion: 4 May 2018 (actual)
Study completion: 4 May 2018 (actual)
First posted: 23 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Drug: CKD-381(formulation I), Drug: CKD-381(formulation II), Drug: D026(Nexium 40mg)Period 1: Test drug(CKD-381 formulation I), Period 2: Test drug(CKD-381 formulation II), Period 3: Reference drug(D026)
Group B	Experimental	Drug: CKD-381(formulation I), Drug: CKD-381(formulation II), Drug: D026(Nexium 40mg)Period 1: Test drug(CKD-381 formulation II), Period 2: Reference drug(D026), Period 3: Test drug(CKD-381 formulation I)
Group C	Experimental	Drug: CKD-381(formulation I), Drug: CKD-381(formulation II), Drug: D026(Nexium 40mg)Period 1: Reference drug(D026), Period 2: Test drug(CKD-381 formulation I), Period 3: Test drug(CKD-381 formulation II)

Who may qualify

Ages: 19 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CKD-381(formulation I)1 tablet administered before the breakfast during 7 days	Drug	Group A, Group B, Group C
CKD-381(formulation II)1 tablet administered before the breakfast during 7 days	Drug	Group A, Group B, Group C
D026(Nexium 40mg)1 tablet administered before the breakfast during 7 days	Drug	Group A, Group B, Group C

Primary outcome

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

12 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
Individual participant dataSharing planned: No

Related trials for GERD

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kyung Sang Yu, M.D principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-381(formulation I), CKD-381(formulation II) and D026(Nexium 40mg) in people with GERD, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) (time frame: 0~24h). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03444402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.