GERDPhase 1NCT05282914
A Study to Compare PK, PD and Safety of UI058 and UIC202004 in Healthy Subjects
A Phase 1 study testing administration of UI058 and administration of UIC202004 in people with GERD, run by Korea United Pharm. Inc. at 1 site in South Korea.
Trial summary
A Study to compare pharmacokinetics, pharmacodynamics and safety of UI058 and UIC202004 in healthy subjects Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- GERD
- What is being tested?
- administration of UI058 and administration of UIC202004
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Feb 2021to 1 Sep 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects able to read and understand a written informed consent, and willing to decide to participate in the study
- Healthy subjects between the ages of 19 and 55 years at screening
- Body weight more than 50.0kg(male)/45.0kg(female)
- Body Mass Index more than 18.0kg/m2 and under 30.0kg/m2
Who cannot join
- Have clinically significant disease that hepatobiliary system, kidney, respiratory system, nervous system, hemato-oncology disease, cardiovascular system
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungbuk national university hospital
Cheongju-si, North Chungcheong, KS001
About this study
Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics Between "UI058" and "UIC202004" in Healthy Subjects
A Study to compare pharmacokinetics, pharmacodynamics and safety of UI058 and UIC202004 in healthy subjects
- Conditions
- GERD
- Being tested
- administration of UI058, administration of UIC202004
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of UI058Drug
Also called Test
UI058 1Tab/day for 7days
administration of UIC202004Drug
Also called Reference
UIC202004 1Tab/day for 7days
| Study group | Role | What they receive |
|---|---|---|
| UI058 | Experimental | Not described Receives: Drug: administration of UI058 |
| UIC202004 | Active comparator | Not described Receives: Drug: administration of UIC202004 |
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 Rabeprazole after multiple dose
Measured: Day 7, 0~24hours
percent change from baseline in integrated gastric acidity for 24-hour interval after 7th dose
evaluation PD for ambulatory 24hour pH monitor
Measured: baseline versus multiple dose during 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start3 Feb 2021
- Primary completion14 Apr 2021
- Study completion1 Sep 2021
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.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea United Pharm. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Kyu Park, Dr, Principal investigator, Chungbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282914
- Sponsor's protocol ID
- KUP-UI058-101
- Status last verified
- Feb 2021
- First submitted
- 5 Jan 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics Between "UI058" and "UIC202004" in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05282914
- Acronym / sponsor ID
- KUP-UI058-101
- Conditions
- GERD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 16 Mar 2022 (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, pharmacodynamics and safety of UI058 and UIC202004 in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UI058 | Experimental | Drug: administration of UI058 |
| UIC202004 | Active comparator | Drug: administration of UIC202004 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects able to read and understand a written informed consent, and willing to decide to participate in the study
- Healthy subjects between the ages of 19 and 55 years at screening
- Body weight more than 50.0kg(male)/45.0kg(female)
- Body Mass Index more than 18.0kg/m2 and under 30.0kg/m2
Key exclusion criteria (3 listed)
- Have clinically significant disease that hepatobiliary system, kidney, respiratory system, nervous system, hemato-oncology disease, cardiovascular system
- 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
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 |
|---|---|---|
| administration of UI058Also: TestUI058 1Tab/day for 7days | Drug | UI058 |
| administration of UIC202004Also: ReferenceUIC202004 1Tab/day for 7days | Drug | UIC202004 |
Primary outcome
AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state
Time frame: Day 7, 0~24hours
evaluation PK for Rabeprazole after multiple dose
percent change from baseline in integrated gastric acidity for 24-hour interval after 7th dose
Time frame: baseline versus multiple dose during 7days
evaluation PD for ambulatory 24hour 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 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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
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Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
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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.
Min Kyu Park, Dr principal investigator
Chungbuk National University 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 administration of UI058 and administration of UIC202004 in people with GERD, run by Korea United Pharm. Inc. 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 4 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 3 Jul 2024. 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: Day 7, 0~24hours). 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 3 Jul 2024.