Gastric or Duodenal UlcerPhase 1NCT06165237
A Study to Evaluate the Drug-drug Interaction and Safety Between "BR6001-1" and "BR6001-2"
A Phase 1 study testing BR6001-1 and BR6001-2 in people with Gastric or Duodenal Ulcer, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this clinical trial is to evaluate the drug-drug interaction and safety between "BR6001-1" and "BR6001-2" in healthy adult volunteers Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric or Duodenal Ulcer
- What is being tested?
- BR6001-1 and BR6001-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Mar 2023to 9 May 2023
- 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
- Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit.
- Those who sign written consent spontaneously to follow the study directions after listening to and understanding sufficient explanation of this clinical trial.
Who cannot join
- Those who have a medical history of gastrointestinal diseases(Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (Except for simple appendectomy, hernia surgery) that may affect the absorption of investigational products.
- Those who have hypersensitivity reaction to investigational products or their additives in addition to other painkillers, anti-inflammatory drugs, antirheumatic drugs, benzimidazole.
- Those who have a history of clinically significant hypersensitivity reaction.
- Those taking anticoagulants, atazanavir, Rilpivirine and methotrexate.
- Those who eat an abnormal food that may affect the absorption, distribution, metabolism and excretion of investigational products or who eat food that may affect drug metabolism.
- Those who take any prescription drugs(including herbal medicines) that may affect characteristics of investigational product within 14 days prior to the date of first administration or who take any over-the-counter (OTC) drugs or vitamins within 10 days prior to the date of first administration (however, if it don't affect subject's safety and study's result according to the judgment of the investigator, they may participate in the study.)
- Those who take inducer and inhibitor of drug metabolizing enzymes such as barbiturates, etc. within 1 month prior to the first administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Trial to Evaluate the Drug-drug Interaction and Safety Between "BR6001-1" and "BR6001-2" in Healthy Adult Volunteers
The purpose of this clinical trial is to evaluate the drug-drug interaction and safety between "BR6001-1" and "BR6001-2" in healthy adult volunteers
- Conditions
- Gastric or Duodenal Ulcer
- Being tested
- BR6001-1, BR6001-2
- Medical subject headings
- Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR6001-1Drug
One tablet administered alone, Once a day
BR6001-2Drug
One tablet administered alone, Once a day
| Study group | Role | What they receive |
|---|---|---|
| BR6001-1+BR6001-2 | Experimental | Not described Receives: Drug: BR6001-1; Drug: BR6001-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss
Area under the Plasma Concentration-Time Curve During Dosing Interval (tau) at Steady State
Measured: 0~24 hours after administration
Cmax,ss
Maximum Concentration of Drug in Plasma at Steady State
Measured: 0~24 hours after administration
The change(%) of Aspirin Reaction Units(ARU) & Thromboxane B2 (TxB2) at 24h after repeated administration (last administration date) compared to baseline (first administration date)
Measured: 0, 6, 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start30 Mar 2023
- Primary completion9 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric or Duodenal UlcerStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165237
- Sponsor's protocol ID
- BR-ARC-CT-101
- Status last verified
- Jan 2024
- First submitted
- 3 Dec 2023
- Last updated
- 1 Feb 2024
- 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 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Drug-drug Interaction and Safety Between "BR6001-1" and "BR6001-2" in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06165237
- Acronym / sponsor ID
- BR-ARC-CT-101
- Conditions
- Gastric or Duodenal Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 11 Dec 2023 (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.
The purpose of this clinical trial is to evaluate the drug-drug interaction and safety between "BR6001-1" and "BR6001-2" in healthy adult volunteers
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BR6001-1+BR6001-2 | Experimental | Drug: BR6001-1, Drug: BR6001-2 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit.
- Those who sign written consent spontaneously to follow the study directions after listening to and understanding sufficient explanation of this clinical trial.
Key exclusion criteria (7 listed)
- Those who have a medical history of gastrointestinal diseases(Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (Except for simple appendectomy, hernia surgery) that may affect the absorption of investigational products.
- Those who have hypersensitivity reaction to investigational products or their additives in addition to other painkillers, anti-inflammatory drugs, antirheumatic drugs, benzimidazole.
- Those who have a history of clinically significant hypersensitivity reaction.
- Those taking anticoagulants, atazanavir, Rilpivirine and methotrexate.
- Those who eat an abnormal food that may affect the absorption, distribution, metabolism and excretion of investigational products or who eat food that may affect drug metabolism.
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 |
|---|---|---|
| BR6001-1One tablet administered alone, Once a day | Drug | BR6001-1+BR6001-2 |
| BR6001-2One tablet administered alone, Once a day | Drug | BR6001-1+BR6001-2 |
Primary outcome
AUCτ,ss
Time frame: 0~24 hours after administration
Area under the Plasma Concentration-Time Curve During Dosing Interval (tau) at Steady State
Cmax,ss
Time frame: 0~24 hours after administration
Maximum Concentration of Drug in Plasma at Steady State
The change(%) of Aspirin Reaction Units(ARU) & Thromboxane B2 (TxB2) at 24h after repeated administration (last administration date) compared to baseline (first administration date)
Time frame: 0, 6, 24 hours after administration
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 1 Feb 2024.
- Individual participant dataSharing planned: No
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Gastric Ulcer
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.
The record lists no contact. Use the official record to reach the sponsor.
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 BR6001-1 and BR6001-2 in people with Gastric or Duodenal Ulcer, run by Boryung Pharmaceutical Co., Ltd 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 2 inclusion and 7 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 1 Feb 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?
AUCτ,ss (time frame: 0~24 hours after administration). The study lists 3 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 1 Feb 2024.