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

  • STATUS
    Recruiting
  • days left to enroll
    33
  • participants needed
    40
  • sponsor
    Boryung Pharmaceutical Co., Ltd
Send
Updated on 5 November 2025
See if I qualify
Accepts healthy volunteers

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.

Description

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.

Details
Condition Diabete Mellitus
Age 19years or above
Clinical Study IdentifierNCT07083401
SponsorBoryung Pharmaceutical Co., Ltd
Last Modified on5 November 2025

Eligibility

 Yes No Not Sure

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center

Since this trial requires contact information verification, you will receive an email with the information you provided asking for your validation. Only after this verification step your referral will be sent to the study site selected.

To verify your phone, please use one of the verification methods below:

Send text message Send automated call

,

,

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

Accepts healthy volunteers

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.