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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg; Drug: Dapagliflozin 10 mg; Drug: Pioglitazone 30 mg; Drug: Metformin HCl 1000 mg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shinyoung Oh; Phone Number: +82 2-708-8000; Email: syoh@boryung.co.kr

Study Locations

• Korea, Republic of
  • Gwanak-gu
    • Seoul, Gwanak-gu, Korea, Republic of, 08779
      • Recruiting
      • H Plus Yangji Hospital
      • Contact: Phone Number: +82 1877-8875

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence B (T / R1+R2+R3); T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C	Drug: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg; Orally administered once per day; Other Names: BR3006; Drug: Dapagliflozin 10 mg; Orally administered once per day; Other Names: BR3006A; Drug: Pioglitazone 30 mg; Orally administered once per day; Other Names: BR3006B; Drug: Metformin HCl 1000 mg; Orally administered once per day; Other Names: BR3006C
Experimental: Sequence A (R1+R2+R3 / T); R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006	Drug: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg; Orally administered once per day; Other Names: BR3006; Drug: Dapagliflozin 10 mg; Orally administered once per day; Other Names: BR3006A; Drug: Pioglitazone 30 mg; Orally administered once per day; Other Names: BR3006B; Drug: Metformin HCl 1000 mg; Orally administered once per day; Other Names: BR3006C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic variable - Cmax	Maximum plasma concentration of "BR3006" and "BR3006A," "BR3006B," and "BR3006C"	From Day 1, 0 hour (pre-dose) to Day 5 after dose administration
Pharmacokinetic variable - AUCt	Area under the drug concentration-time curve over the time interval of "BR3006" and "BR3006A," "BR3006B," and "BR3006C"	From Day 1, 0 hour (pre-dose) to Day 5 after dose administration

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2025
• Primary Completion (Estimated): July 3, 2026
• Study Completion (Estimated): July 3, 2026

Study Registration Dates

• First Submitted: July 16, 2025
• First Submitted That Met QC Criteria: July 16, 2025
• First Posted (Actual): July 24, 2025

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Dapagliflozin; Pioglitazone; Metformin HCl
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Pioglitazone; Metformin; Dapagliflozin
• Other Study ID Numbers: BR-DPMC-CT-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No