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

NCT06165237 | Completed Phase 1

• 1 other identifier: BR-ARC-CT-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gastric or Duodenal Ulcer

Outcome Measures

Primary Outcomes (3)

• AUCτ,ss

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

  0~24 hours after administration

• Cmax,ss

  Maximum Concentration of Drug in Plasma at Steady State

  0~24 hours after administration

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

  0, 6, 24 hours after administration

Study Arms (1)

BR6001-1+BR6001-2

EXPERIMENTAL

Drug: BR6001-1; Drug: BR6001-2

Interventions

BR6001-1 DRUG

One tablet administered alone, Once a day

BR6001-1+BR6001-2

BR6001-2 DRUG

One tablet administered alone, Once a day

BR6001-1+BR6001-2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

ChungBuk National University Hospital

Jungbuk, South Korea

Location

MeSH Terms

Conditions

Duodenal Ulcer

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 11, 2023
• Study Start: March 30, 2023
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)