Overview
A Study to Evaluate the Drug-drug Interaction and Safety Between "BR6001-1" and "BR6001-2"
Status:
Completed
Completed
Trial end date:
2023-05-09
2023-05-09
Target enrollment:
0
0
Participant gender:
All
All
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 volunteersPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Boryung Pharmaceutical Co., LtdCriteria
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