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CompletedNCT06165237Updated Feb 1, 2024

A Study to Evaluate the Drug-drug Interaction and Safety Between "BR6001-1" and "BR6001-2"

A Phase 1 interventional study of BR6001-1 and BR6001-2 in Gastric or Duodenal Ulcer, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-01.

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

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Mar 2023, registered Dec 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
19 Years to 55 Years
Sex
All
01

Study summary

The purpose of this clinical trial is to evaluate the drug-drug interaction and safety between "BR6001-1" and "BR6001-2" in healthy adult volunteers

02

Conditions studied

  • Gastric or Duodenal Ulcer

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03

In context

Duodenal Ulcer

75 studies on the registry are indexed under Duodenal Ulcer; 5 are open to participants now.

This study's enrollment of 30 is below the median of 284 across 50 interventional studies indexed under Duodenal Ulcer.

Browse Duodenal Ulcer studies →

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 to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit.
  • Those who sign written consent spontaneously to follow the study directions after listening to and understanding sufficient explanation of this clinical trial.

Exclusion criteria

Exclusion Criteria:

  • Those who have a medical history of gastrointestinal diseases(Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (Except for simple appendectomy, hernia surgery) that may affect the absorption of investigational products.
  • Those who have hypersensitivity reaction to investigational products or their additives in addition to other painkillers, anti-inflammatory drugs, antirheumatic drugs, benzimidazole.
  • Those who have a history of clinically significant hypersensitivity reaction.
  • Those taking anticoagulants, atazanavir, Rilpivirine and methotrexate.
  • Those who eat an abnormal food that may affect the absorption, distribution, metabolism and excretion of investigational products or who eat food that may affect drug metabolism.
  • Those who take any prescription drugs(including herbal medicines) that may affect characteristics of investigational product within 14 days prior to the date of first administration or who take any over-the-counter (OTC) drugs or vitamins within 10 days prior to the date of first administration (however, if it don't affect subject's safety and study's result according to the judgment of the investigator, they may participate in the study.)
  • Those who take inducer and inhibitor of drug metabolizing enzymes such as barbiturates, etc. within 1 month prior to the first administration
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    BR6001-1+BR6001-2

    Drug: BR6001-1 · Drug: BR6001-2

Interventions

  • DrugBR6001-1

    One tablet administered alone, Once a day

  • DrugBR6001-2

    One tablet administered alone, Once a day

06

What researchers measure

Primary outcomes

  1. AUCτ,ss

    Area under the Plasma Concentration-Time Curve During Dosing Interval (tau) at Steady State

    Time frame: 0~24 hours after administration

  2. Cmax,ss

    Maximum Concentration of Drug in Plasma at Steady State

    Time frame: 0~24 hours after administration

  3. The change(%) of Aspirin Reaction Units(ARU) & Thromboxane B2 (TxB2) at 24h after repeated administration (last administration date) compared to baseline (first administration date)

    Time frame: 0, 6, 24 hours after administration

07

Study locations

1 site
  • ChungBuk National University Hospital
    Chungbuk, 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 Feb 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06165237
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Dec 11, 2023
Start date
Mar 30, 2023
Primary completion
May 9, 2023
Completion
May 9, 2023
Last update
Feb 1, 2024

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 Jan 2024. You cannot join it, but the record below documents what was studied.

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