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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-03

Study Completion Date

2026-07-03

Brief Summary

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This was an open-label, randomized, fasting, 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

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A total of 52 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 fasting.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A (R1+R2+R3 / T)

R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006

Group Type EXPERIMENTAL

Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg

Intervention Type DRUG

Orally administered once per day

Dapagliflozin 10 mg

Intervention Type DRUG

Orally administered once per day

Pioglitazone 30 mg

Intervention Type DRUG

Orally administered once per day

Metformin HCl 1000 mg

Intervention Type DRUG

Orally administered once per day

Sequence B (T / R1+R2+R3)

T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C

Group Type EXPERIMENTAL

Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg

Intervention Type DRUG

Orally administered once per day

Dapagliflozin 10 mg

Intervention Type DRUG

Orally administered once per day

Pioglitazone 30 mg

Intervention Type DRUG

Orally administered once per day

Metformin HCl 1000 mg

Intervention Type DRUG

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

Intervention Type DRUG

Dapagliflozin 10 mg

Orally administered once per day

Intervention Type DRUG

Pioglitazone 30 mg

Orally administered once per day

Intervention Type DRUG

Metformin HCl 1000 mg

Orally administered once per day

Intervention Type DRUG

Other Intervention Names

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BR3006 BR3006A BR3006B BR3006C

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* Those who are pregnant, suspected of pregnancy, or nursing
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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H Plus Yangji Hospital

Seoul, Gwanak-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Shinyoung Oh

Role: CONTACT

+82 2-708-8000

Facility Contacts

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Role: primary

+82 1877-8875

Other Identifiers

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BR-DPMC-CT-104

Identifier Type: -

Identifier Source: org_study_id

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