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

Boryung

Status and phase: Completed; Phase 1

Conditions: Gastric or Duodenal Ulcer

Treatments: Drug: BR6001-1; Drug: BR6001-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06165237

BR-ARC-CT-101

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

BR6001-1+BR6001-2

Experimental group

Treatment:

Drug: BR6001-2

Drug: BR6001-1