Gastric or Duodenal Ulcer
Conditions
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
Interventions
DRUGBR6001-1
One tablet administered alone, Once a day
DRUGBR6001-2
One tablet administered alone, Once a day
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCτ,ss | 0~24 hours after administration | Area under the Plasma Concentration-Time Curve During Dosing Interval (tau) at Steady State |
| Cmax,ss | 0~24 hours after administration | Maximum Concentration of Drug in Plasma at Steady State |
| 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 | — |
Countries
South Korea
Outcome results
None listed