Gastric or Duodenal UlcersPhase 1NCT05959486
A Study to Evaluate the Pharmacokinetics and Safety Between Single Administration of "BR6002" and Coadministration of "BR6002A" and "BR6002B" Under Fasting Conditions in Healthy Adult Volunteers
A Phase 1 study testing BR6002A, BR6002B and BR6002 in people with Gastric or Duodenal Ulcers, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this clinical trial is to evaluate the pharmacokinetics and safety between single administration of "BR6002" and coadministration of "BR6002A" and "BR6002B" under fasting conditions 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 Ulcers
- What is being tested?
- BR6002A, BR6002B and BR6002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jul 2023to 24 Aug 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 55 kg or more for men and 50 kg or more for women and have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
- Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception (In the case of a female subject, hormone drugs is excluded) accepted in clinical trial from the date of the first administration of the investigational products to 7 days after the last administration and disagrees to provide their sperm or ovum.
- Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.
- Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
Who cannot join
- Those who have clinically significant diseases or past history of the gastrointestinal system, cardiovascular system, endocrine system, respiratory system, hemato-oncologic disease, infectious disease, kidney
- \& genitourinary system, neuropsychiatric system, musculoskeletal system, immune system, ENT system, skin system, ophthalmic system.
- Those who have a medical history of gastrointestinal surgery (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
- Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 1 month prior to the first day of administration or have taken ETC, OTC, herbal medicine and health functional foods concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs)
- Those who have participated in other clinical trials or bioequivalence tests and administered their investigational products within 6 months prior to the first administration date.
- In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Research Center, H PLUS Yangji Hospital
Seoul, Gwanakgu, 08779
About this study
Official title: An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 4-period, Full Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety Between Single Administration of "BR6002" and Coadministration of "BR6002A" and "BR6002B" in Healthy Adult Volunteers
The purpose of this clinical trial is to evaluate the pharmacokinetics and safety between single administration of "BR6002" and coadministration of "BR6002A" and "BR6002B" under fasting conditions in healthy adult volunteers
- Conditions
- Gastric or Duodenal Ulcers
- Being tested
- BR6002A, BR6002B, BR6002
- Medical subject headings
- Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR6002ADrug
One tablet administered alone
BR6002BDrug
One tablet administered alone
BR6002Drug
One capsule administered alone
| Study group | Role | What they receive |
|---|---|---|
| BR6002A+BR6002B | Active comparator | Not described Receives: Drug: BR6002A; Drug: BR6002B |
| BR6002 | Experimental | Not described Receives: Drug: BR6002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ
Area under the concentration-time curve from time zero to time τ
Measured: 0-12 hours after administration
Cmax
Maximum concentration of drug in plasma
Measured: 0-12 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 posted25 Jul 2023
- Study start14 Jul 2023
- Primary completion24 Aug 2023
- Study completion24 Aug 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 UlcersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT05959486
- Sponsor's protocol ID
- BR-ARC-CT-102
- Status last verified
- Dec 2023
- First submitted
- 17 Jul 2023
- Last updated
- 5 Dec 2023
- 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 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 4-period, Full Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety Between Single Administration of "BR6002" and Coadministration of "BR6002A" and "BR6002B" in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05959486
- Acronym / sponsor ID
- BR-ARC-CT-102
- Conditions
- Gastric or Duodenal Ulcers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 25 Jul 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 pharmacokinetics and safety between single administration of "BR6002" and coadministration of "BR6002A" and "BR6002B" under fasting conditions in healthy adult volunteers
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BR6002A+BR6002B | Active comparator | Drug: BR6002A, Drug: BR6002B |
| BR6002 | Experimental | Drug: BR6002 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Those who weigh 55 kg or more for men and 50 kg or more for women and have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
- Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception (In the case of a female subject, hormone drugs is excluded) accepted in clinical trial from the date of the first administration of the investigational products to 7 days after the last administration and disagrees to provide their sperm or ovum.
- Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.
- Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
Key exclusion criteria (6 listed)
- Those who have clinically significant diseases or past history of the gastrointestinal system, cardiovascular system, endocrine system, respiratory system, hemato-oncologic disease, infectious disease, kidney
- \& genitourinary system, neuropsychiatric system, musculoskeletal system, immune system, ENT system, skin system, ophthalmic system.
- Those who have a medical history of gastrointestinal surgery (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
- Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 1 month prior to the first day of administration or have taken ETC, OTC, herbal medicine and health functional foods concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs)
- Those who have participated in other clinical trials or bioequivalence tests and administered their investigational products within 6 months prior to the first administration date.
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 |
|---|---|---|
| BR6002AOne tablet administered alone | Drug | BR6002A+BR6002B |
| BR6002BOne tablet administered alone | Drug | BR6002A+BR6002B |
| BR6002One capsule administered alone | Drug | BR6002 |
Primary outcome
AUCτ
Time frame: 0-12 hours after administration
Area under the concentration-time curve from time zero to time τ
Cmax
Time frame: 0-12 hours after administration
Maximum concentration of drug in plasma
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 5 Dec 2023.
- Individual participant dataSharing planned: No
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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 BR6002A, BR6002B and BR6002 in people with Gastric or Duodenal Ulcers, 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 4 inclusion and 6 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 5 Dec 2023. 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 (time frame: 0-12 hours after administration). 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 5 Dec 2023.