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NCT Number: NCT07083401

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

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.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

Location status: Recruiting

Location contact

CONTACT

+82 1877-8875

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Female subjects who are pregnant, suspected of pregnancy, or nursing

Treatment and study plan

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

Drug

Orally administered once per day

Other names: BR3006

Dapagliflozin 10 mg

Drug

Orally administered once per day

Other names: BR3006A

Pioglitazone 30 mg

Drug

Orally administered once per day

Other names: BR3006B

Metformin HCl 1000 mg

Drug

Orally administered once per day

Other names: BR3006C

Primary outcomes

  1. 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"

  2. 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"

Study contacts

Contact information is provided by the study sponsor or research team.

Shinyoung Oh

CONTACT

[email protected]

+82 2-708-8000

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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