GERDPhase 1NCT03558425
A Study to Compare PK, PD and Safety of CKD-381 and D026 in Healthy Subjects
A Phase 1 study testing CKD-381 and D026 in people with GERD, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy 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 and D026
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jun 2018to 14 Sep 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 Investigational product, additives or benzimidazole family.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multiple-dose, and Crossover Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of CKD-381 and D026 in Healthy Subjects
A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy subjects
- Conditions
- GERD
- Being tested
- CKD-381, D026
- Keywords
- CKD-381, D026
- 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-381Drug
1 tablet administered before the breakfast during 7 days
D026Drug
1 tablet administered before the breakfast during 7 days
| Study group | Role | What they receive |
|---|---|---|
| TR group | Experimental | Period 1: Test drug(CKD-381) Period 2: Reference drug(D026) Receives: Drug: D026 |
| RT group | Experimental | Period 1: Reference drug(D026) Period 2: Test drug(CKD-381) Receives: Drug: CKD-381 |
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 for Esomeprazole after multiple dose
Measured: 0~24h
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose
Evaluation PD for ambulatory 24hr pH monitor
Measured: Baseline versus Multiple dose during 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start27 Jun 2018
- Primary completion14 Sep 2018
- Study completion14 Sep 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung Sang Yu, M.D., Ph.D., Principal investigator, Department of Clinical Pharmacology and Therapeutics, Seoul Nat'l University College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558425
- Sponsor's protocol ID
- 173BE18010
- Status last verified
- Jun 2018
- First submitted
- 1 Jun 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, and Crossover Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of CKD-381 and D026 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03558425
- Acronym / sponsor ID
- 173BE18010
- Conditions
- GERD
- Keywords
- CKD-381, D026
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 15 Jun 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 subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TR group | Experimental | Drug: D026Period 1: Test drug(CKD-381) Period 2: Reference drug(D026) |
| RT group | Experimental | Drug: CKD-381Period 1: Reference drug(D026) Period 2: Test drug(CKD-381) |
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 Investigational product, 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-3811 tablet administered before the breakfast during 7 days | Drug | RT group |
| D0261 tablet administered before the breakfast during 7 days | Drug | TR group |
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 for Esomeprazole after multiple dose
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose
Time frame: Baseline versus Multiple dose during 7 days
Evaluation PD for ambulatory 24hr pH monitor
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 12 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for GERD
RecruitingObservational study
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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., Ph.D. principal investigator
Department of Clinical Pharmacology and Therapeutics, Seoul Nat'l 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 and D026 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 12 Oct 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2018.