CClinicalTrials.gg
CompletedNCT06879132Updated Mar 17, 2025

A Study to Evaluate the Pharmacokinetics and Safety of BR3409 and Co-administration of BR3409-1 and BR3409-2 in Healthy Volunteers Under Fed Conditions

A Phase 1 interventional study of BR3409 and BR3409-1 in Type 2 Diabetes, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2024, registered Mar 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

The purpose of this clinical study is to evaluate the pharmacokinetics and safety of BR3409 and co-administration of BR3409-1 and BR3409-2 in healthy volunteers Under Fed Conditions

02

Conditions studied

  • Type 2 Diabetes
03

In context

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Those have body mass index (BMI: weight(kg)/the square of {height(m)}) within the range of 18.0 to 30.0 at screening visit.

    • For men, Those who weigh 55 kg or more
    • For women, Those who weigh 50 kg or more
  • Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
  • Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial*(Except for hormone drugs) from the date of consent to 56 days after the last administration and disagree to provide their sperm or ovum.

    • Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.

Exclusion criteria

Exclusion Criteria:

  • Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days before the first administration date or have taken drugs concerned about affecting this clinical trial within 10 days before the first administration date. (However, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
  • Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before the first day of administration. (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
  • Those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
  • In the case of a female subject, those suspected pregnancy or pregnant woman, lactating woman.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    BR3409

    Drug: BR3409

  • Active comparator
    BR3409-1 + BR3409-2

    Drug: BR3409-1 · Drug: BR3409-2

Interventions

  • DrugBR3409

    One tablet administered alone

  • DrugBR3409-1

    One tablet administered alone

  • DrugBR3409-2

    One tablet administered alone

06

What researchers measure

Primary outcomes

  1. AUCτ

    Area under the plasma drug concentration-time curve from 0 to time τ

    Time frame: 0~48 hours after administration

  2. Cmax

    Maximum Concentration of Drug in Plasma

    Time frame: 0~48 hours after administration

07

Study locations

1 site
  • Clinical Research Center, H PLUS Yangji Hospital
    Seoul, Gwanakgu 08779, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06879132
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Mar 17, 2025
Start date
Nov 5, 2024
Primary completion
Dec 7, 2024
Completion
Dec 7, 2024
Last update
Mar 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion