Type 2 Diabetes MellitusPhase 1NCT06226727
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-1" and "BR1019-2"
A Phase 1 study testing BR1019, BR1019-1 and BR1019-2 in people with Type 2 Diabetes Mellitus and Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-1" and "BR1019-2" in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Essential Hypertension
- What is being tested?
- BR1019, BR1019-1 and BR1019-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Feb 2024to 31 Mar 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit
- In case of a male subject, Those who weigh 50 kg or more
- In case of a female subject, Those who weigh 45 kg or more
- Those who decide to voluntarily participate after listening to and understanding the detailed explanation of this clinical trial and who sign a written consent to comply with the subject's precautions during this clinical trial.
Who cannot join
- Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken ETC, OTC, Oriental medicine, Health functional food 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, etc.)
- Those who have participated in bioequivalence tests or other clinical trials administered their investigational products within 6 months prior to the first administration date. (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
- Those who have a medical history of gastrectomy(Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
- Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or its products, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
- 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: A Randomized, Open-label, Single Dose, Two-way Replicate Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-1" and "BR1019-2" in Healthy Volunteers
The objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-1" and "BR1019-2" in healthy volunteers
- Conditions
- Type 2 Diabetes Mellitus, Essential Hypertension
- Being tested
- BR1019, BR1019-1, BR1019-2
- Medical subject headings
- Diabetes Mellitus, Type 2, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR1019Drug
One tablet administered alone
BR1019-1Drug
One tablet administered alone
BR1019-2Drug
One tablet administered alone
| Study group | Role | What they receive |
|---|---|---|
| Sequence Group A | Experimental | The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4.
*Sequence Group A [Period 1, 3] Co-administration of BR1019-1(R1) and BR1019-2(R2). [Period 2, 4] Administration of BR1019(T) Receives: Drug: BR1019; Drug: BR1019-1; Drug: BR1019-2 |
| Sequence Group B | Experimental | The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4.
*Sequence Group B [Period 1, 3] Administration of BR1019(T) [Period 2, 4] Co-administration of BR1019-1(R1) and BR1019-2(R2). Receives: Drug: BR1019; Drug: BR1019-1; Drug: BR1019-2 |
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: 0-48 hours after administration
Cmax
Maximum concentration of drug in plasma
Measured: 0-48 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 posted26 Jan 2024
- Study start14 Feb 2024
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 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
- NCT06226727
- Sponsor's protocol ID
- BR-FDC-CT-103
- Status last verified
- Apr 2024
- First submitted
- 18 Jan 2024
- Last updated
- 2 Apr 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 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Two-way Replicate Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-1" and "BR1019-2" in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06226727
- Acronym / sponsor ID
- BR-FDC-CT-103
- Conditions
- Type 2 Diabetes Mellitus, Essential Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 26 Jan 2024 (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 objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-1" and "BR1019-2" in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence Group A | Experimental | Drug: BR1019, Drug: BR1019-1, Drug: BR1019-2The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4. *Sequence Group A [Period 1, 3] Co-administration of BR1019-1(R1) and BR1019-2(R2). [Period 2, 4] Administration of BR1019(T) |
| Sequence Group B | Experimental | Drug: BR1019, Drug: BR1019-1, Drug: BR1019-2The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4. *Sequence Group B [Period 1, 3] Administration of BR1019(T) [Period 2, 4] Co-administration of BR1019-1(R1) and BR1019-2(R2). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit
- Those who decide to voluntarily participate after listening to and understanding the detailed explanation of this clinical trial and who sign a written consent to comply with the subject's precautions during this clinical trial.
Key exclusion criteria (5 listed)
- Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken ETC, OTC, Oriental medicine, Health functional food 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, etc.)
- Those who have participated in bioequivalence tests or other clinical trials administered their investigational products within 6 months prior to the first administration date. (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
- Those who have a medical history of gastrectomy(Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
- Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or its products, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
- In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
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 |
|---|---|---|
| BR1019One tablet administered alone | Drug | Sequence Group A, Sequence Group B |
| BR1019-1One tablet administered alone | Drug | Sequence Group A, Sequence Group B |
| BR1019-2One tablet administered alone | Drug | Sequence Group A, Sequence Group B |
Primary outcome
AUCτ
Time frame: 0-48 hours after administration
Area under the concentration-time curve from time zero to time τ
Cmax
Time frame: 0-48 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 2 Apr 2024.
- 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 BR1019, BR1019-1 and BR1019-2 in people with Type 2 Diabetes Mellitus and Essential Hypertension, 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 5 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 2 Apr 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 (time frame: 0-48 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 2 Apr 2024.