Type 2 Diabetes MellitusPhase 1NCT06289920
A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fasting Conditions in Healthy Adult Volunteers
A Phase 1 study testing BR3005, BR3005-1 and BR3005-2 in people with Type 2 Diabetes Mellitus, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fasting conditions in healthy adult 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
- What is being tested?
- BR3005, BR3005-1 and BR3005-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2024to 28 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 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 taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs 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 other clinical trials(including bioequivalence tests) and 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 gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
- 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, 2-period, Crossover Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" in Healthy Adult Volunteers
The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fasting conditions in healthy adult volunteers
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- BR3005, BR3005-1, BR3005-2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR3005Drug
One tablet administered alone, Once a day
BR3005-1Drug
One tablet administered alone, Once a day
BR3005-2Drug
One tablet administered alone, Once a day
| Study group | Role | What they receive |
|---|---|---|
| BR3005 | Experimental | Not described Receives: Drug: BR3005 |
| BR3005-1+BR3005-2 | Active comparator | Not described Receives: Drug: BR3005-1; Drug: BR3005-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ
Area under the Plasma Concentration-Time Curve During a Dosing Interval (tau)
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 posted4 Mar 2024
- Study start2 Mar 2024
- Primary completion28 Mar 2024
- Study completion28 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
- 47 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
- NCT06289920
- Sponsor's protocol ID
- BR-EMC-CT-102
- Status last verified
- May 2024
- First submitted
- 26 Feb 2024
- Last updated
- 24 May 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 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Fasting, Single Dose, 2-sequence, 2-period, Crossover Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06289920
- Acronym / sponsor ID
- BR-EMC-CT-102
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 4 Mar 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 compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fasting conditions in healthy adult volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BR3005 | Experimental | Drug: BR3005 |
| BR3005-1+BR3005-2 | Active comparator | Drug: BR3005-1, Drug: BR3005-2 |
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 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 (4 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 drugs 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 other clinical trials(including bioequivalence tests) and 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 gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
- 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 |
|---|---|---|
| BR3005One tablet administered alone, Once a day | Drug | BR3005 |
| BR3005-1One tablet administered alone, Once a day | Drug | BR3005-1+BR3005-2 |
| BR3005-2One tablet administered alone, Once a day | Drug | BR3005-1+BR3005-2 |
Primary outcome
AUCτ
Time frame: 0~48 hours after administration
Area under the Plasma Concentration-Time Curve During a Dosing Interval (tau)
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 24 May 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 BR3005, BR3005-1 and BR3005-2 in people with Type 2 Diabetes Mellitus, 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 4 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 24 May 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 24 May 2024.