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CompletedNCT06289933Updated May 24, 2024

A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fed Conditions in Healthy Adult Volunteers

A Phase 1 interventional study of BR3005 and BR3005-1 in Type2 Diabetes Mellitus, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-24.

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

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fed conditions in healthy adult volunteers

02

Conditions studied

  • Type2 Diabetes Mellitus
03

In context

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 143 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Those who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit

    • In case of a male subject, Those who weigh 50 kg or more
    • In case of a female subject, Those who weigh 45 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.

Exclusion criteria

Exclusion Criteria:

  • Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (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 prior to the first administration date.(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 surgery 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, 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
    BR3005

    Drug: BR3005

  • Active comparator
    BR3005-1+BR3005-2

    Drug: BR3005-1 · Drug: BR3005-2

Interventions

  • DrugBR3005

    One tablet administered alone, Once a day

  • DrugBR3005-1

    One tablet administered alone, Once a day

  • DrugBR3005-2

    One tablet administered alone, Once a day

06

What researchers measure

Primary outcomes

  1. AUCτ

    Area under the Plasma Concentration-Time Curve During a Dosing Interval (tau)

    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, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2024 to primary completion in Apr 2024, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2024
First posted
Mar 4, 2024
StartActual
Mar 5, 2024
Primary completionActual
Apr 3, 2024
CompletionActual
Apr 3, 2024
Last update
May 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06289933
Responsible party
Sponsor
First posted
Mar 4, 2024
Start date
Mar 5, 2024
Primary completion
Apr 3, 2024
Completion
Apr 3, 2024
Last update
May 24, 2024

Oversight

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

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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