A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fed)

NCT07083401 | Recruiting Phase 1

• 1 other identifier: BR-DPMC-CT-105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabete Mellitus

Keywords

Dapagliflozin; Pioglitazone; Metformin HCl

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic variable - AUCt

  Area under the drug concentration-time curve over the time interval of "BR3006"

  [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]

• Pharmacokinetic variable - Cmax

  Maximum plasma concentration of "BR3006"

  [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]

Study Arms (2)

Sequence A (R1+R2+R3 / T)

EXPERIMENTAL

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

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

Drug: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg; Drug: Dapagliflozin 10 mg; Drug: Pioglitazone 30 mg; Drug: Metformin HCl 1000 mg

Interventions

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

Orally administered once per day

Also known as: BR3006

Sequence A (R1+R2+R3 / T); Sequence B (T / R1+R2+R3)

Dapagliflozin 10 mg DRUG

Orally administered once per day

Also known as: BR3006A

Sequence A (R1+R2+R3 / T); Sequence B (T / R1+R2+R3)

Pioglitazone 30 mg DRUG

Orally administered once per day

Also known as: BR3006B

Sequence A (R1+R2+R3 / T); Sequence B (T / R1+R2+R3)

Metformin HCl 1000 mg DRUG

Orally administered once per day

Also known as: BR3006C

Sequence A (R1+R2+R3 / T); Sequence B (T / R1+R2+R3)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

dapagliflozin; Pioglitazone; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Central Study Contacts

Shinyoung Oh

CONTACT

+82 2-708-8000; syoh@boryung.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: July 5, 2025
• Primary Completion (Estimated): July 5, 2026
• Study Completion (Estimated): July 5, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)