A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fasting)
NCT ID: NCT07083388
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
52 participants
INTERVENTIONAL
2025-07-03
2026-07-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence A (R1+R2+R3 / T)
R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006
Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg
Orally administered once per day
Dapagliflozin 10 mg
Orally administered once per day
Pioglitazone 30 mg
Orally administered once per day
Metformin HCl 1000 mg
Orally administered once per day
Sequence B (T / R1+R2+R3)
T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C
Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg
Orally administered once per day
Dapagliflozin 10 mg
Orally administered once per day
Pioglitazone 30 mg
Orally administered once per day
Metformin HCl 1000 mg
Orally administered once per day
Interventions
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Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg
Orally administered once per day
Dapagliflozin 10 mg
Orally administered once per day
Pioglitazone 30 mg
Orally administered once per day
Metformin HCl 1000 mg
Orally administered once per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Those who have undergone gastrointestinal surgeries or have gastrointestinal diseases (except appendectomy or hernia surgery) that may affect the absorption of the investigational products
* Those who are pregnant, suspected of pregnancy, or nursing
19 Years
ALL
Yes
Sponsors
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Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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H Plus Yangji Hospital
Seoul, Gwanak-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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BR-DPMC-CT-104
Identifier Type: -
Identifier Source: org_study_id
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