Diabete MellitusPhase 1NCT07083401
A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fed)
A Phase 1 study testing Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg, Dapagliflozin 10 mg and Pioglitazone 30 mg in people with Diabete Mellitus, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
This was an open-label, randomized, fed, single-dose, 2-sequence, 2- period crossover study to evaluate the pharmacokinetics and safety between single oral administration of "BR3006" and co-administration of "BR3006A", "BR3006B," and "BR3006C" 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
- Diabete Mellitus
- What is being tested?
- Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg, Dapagliflozin 10 mg and Pioglitazone 30 mg
- 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
- 5 Jul 2025to 5 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Adults aged over 19 at the time of consent
- Those who are eligible to participate in the clinical trial at the discretion of the principal investigator (or a subinvestigator) through laboratory tests such as hematology tests, blood chemistry tests, serology tests, urine tests, and electrocardiogram (ECG) tests that were planned/performed with specification to the investigational product.
- Those who provided written consent after receiving sufficient explanations and fully understood the objective and details of this clinical trial, the characteristics of the investigational product, and the expected adverse events.
Who cannot join
- Those who have administered investigational products within 6 months from the first dose administration date in another clinical trial (including bioequivalent studies) (The end of study date is based on the last dose administration date.)
- Those who have undergone gastrointestinal surgeries or have gastrointestinal diseases (except appendectomy or hernia surgery) that may affect the absorption of the investigational products
- Female subjects who are pregnant, suspected of pregnancy, or nursing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
H Plus Yangji Hospital
Seoul, Gwanak-gu, 08779
+82 1877-8875
About this study
Official title: An Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between Single Oral Administration of "BR3006" and Co-administration of "BR3006A", "BR3006B" and "BR3006C" in Healthy Adult Volunteers
This was an open-label, randomized, fed, single-dose, 2-sequence, 2- period crossover study to evaluate the pharmacokinetics and safety between single oral administration of "BR3006" and co-administration of "BR3006A", "BR3006B," and "BR3006C" in healthy adult volunteers.
Read the detailed description
A total of 40 healthy volunteers will be enrolled to evaluate the pharmacokinetics and safety profiles of the study drug (one combination tablet of dapagliflozin 10 mg/pioglitazone 30 mg/metformin HCl 1000 mg) and the comparator (co-administration of dapagliflozin 10 mg, pioglitazone 30 mg, and metformin HCl 1000 mg, one tablet each, respectively) while fed.
- Conditions
- Diabete Mellitus
- Being tested
- Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg, Dapagliflozin 10 mg, Pioglitazone 30 mg, Metformin HCl 1000 mg
- Keywords
- Dapagliflozin, Pioglitazone, Metformin HCl
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mgDrug
Also called BR3006
Orally administered once per day
Dapagliflozin 10 mgDrug
Also called BR3006A
Orally administered once per day
Pioglitazone 30 mgDrug
Also called BR3006B
Orally administered once per day
Metformin HCl 1000 mgDrug
Also called BR3006C
Orally administered once per day
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (R1+R2+R3 / T) | Experimental | R1+R2+R3: BR3006A, BR3006B, and BR3006C; T:
BR3006 Receives: Drug: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg; Drug: Dapagliflozin 10 mg; Drug: Pioglitazone 30 mg; Drug: Metformin HCl 1000 mg |
| Sequence B (T / R1+R2+R3) | Experimental | T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C Receives: Drug: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg; Drug: Dapagliflozin 10 mg; Drug: Pioglitazone 30 mg; Drug: Metformin HCl 1000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variable - AUCt
Area under the drug concentration-time curve over the time interval of "BR3006"
Measured: [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]
Pharmacokinetic variable - Cmax
Maximum plasma concentration of "BR3006"
Measured: [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start5 Jul 2025
- Primary completion5 Jul 2026 (estimated)
- Study completion5 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete 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
- 40 participants (estimated)
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
- NCT07083401
- Sponsor's protocol ID
- BR-DPMC-CT-105
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 24 Jul 2025
- 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 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between Single Oral Administration of "BR3006" and Co-administration of "BR3006A", "BR3006B" and "BR3006C" in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07083401
- Acronym / sponsor ID
- BR-DPMC-CT-105
- Conditions
- Diabete Mellitus
- Keywords
- Dapagliflozin, Pioglitazone, Metformin HCl
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- 5 Jul 2026 (estimated)
- Study completion
- 5 Jul 2026 (estimated)
- First posted
- 24 Jul 2025 (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.
This was an open-label, randomized, fed, single-dose, 2-sequence, 2- period crossover study to evaluate the pharmacokinetics and safety between single oral administration of "BR3006" and co-administration of "BR3006A", "BR3006B," and "BR3006C" in healthy adult volunteers.
Detailed description
A total of 40 healthy volunteers will be enrolled to evaluate the pharmacokinetics and safety profiles of the study drug (one combination tablet of dapagliflozin 10 mg/pioglitazone 30 mg/metformin HCl 1000 mg) and the comparator (co-administration of dapagliflozin 10 mg, pioglitazone 30 mg, and metformin HCl 1000 mg, one tablet each, respectively) while fed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A (R1+R2+R3 / T) | Experimental | Drug: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg, Drug: Dapagliflozin 10 mg, Drug: Pioglitazone 30 mg, Drug: Metformin HCl 1000 mgR1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006 |
| Sequence B (T / R1+R2+R3) | Experimental | Drug: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg, Drug: Dapagliflozin 10 mg, Drug: Pioglitazone 30 mg, Drug: Metformin HCl 1000 mgT: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged over 19 at the time of consent
- Those who are eligible to participate in the clinical trial at the discretion of the principal investigator (or a subinvestigator) through laboratory tests such as hematology tests, blood chemistry tests, serology tests, urine tests, and electrocardiogram (ECG) tests that were planned/performed with specification to the investigational product.
- Those who provided written consent after receiving sufficient explanations and fully understood the objective and details of this clinical trial, the characteristics of the investigational product, and the expected adverse events.
Key exclusion criteria (3 listed)
- Those who have administered investigational products within 6 months from the first dose administration date in another clinical trial (including bioequivalent studies) (The end of study date is based on the last dose administration date.)
- Those who have undergone gastrointestinal surgeries or have gastrointestinal diseases (except appendectomy or hernia surgery) that may affect the absorption of the investigational products
- Female subjects who are pregnant, suspected of pregnancy, or nursing
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 |
|---|---|---|
| Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mgAlso: BR3006Orally administered once per day | Drug | Sequence A (R1+R2+R3 / T), Sequence B (T / R1+R2+R3) |
| Dapagliflozin 10 mgAlso: BR3006AOrally administered once per day | Drug | Sequence A (R1+R2+R3 / T), Sequence B (T / R1+R2+R3) |
| Pioglitazone 30 mgAlso: BR3006BOrally administered once per day | Drug | Sequence A (R1+R2+R3 / T), Sequence B (T / R1+R2+R3) |
| Metformin HCl 1000 mgAlso: BR3006COrally administered once per day | Drug | Sequence A (R1+R2+R3 / T), Sequence B (T / R1+R2+R3) |
Primary outcome
Pharmacokinetic variable - AUCt
Time frame: [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]
Area under the drug concentration-time curve over the time interval of "BR3006"
Pharmacokinetic variable - Cmax
Time frame: [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]
Maximum plasma concentration of "BR3006"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- 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.
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 Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg, Dapagliflozin 10 mg and Pioglitazone 30 mg in people with Diabete 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 3 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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shinyoung Oh (+82 2-708-8000, syoh@boryung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic variable - AUCt (time frame: [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose 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 Jul 2025.