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

NCT ID: NCT06165237

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2023-05-09

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BR6001-1+BR6001-2

Group Type: EXPERIMENTAL

BR6001-1

Intervention Type: DRUG

One tablet administered alone, Once a day

BR6001-2

Intervention Type: DRUG

One tablet administered alone, Once a day

Interventions

BR6001-1

One tablet administered alone, Once a day

Intervention Type: DRUG

BR6001-2

One tablet administered alone, Once a day

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ChungBuk National University Hospital

Jungbuk, , South Korea

Countries

South Korea

Other Identifiers

BR-ARC-CT-101

Identifier Type: -

Identifier Source: org_study_id