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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06165237
Other study ID # BR-ARC-CT-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 30, 2023
Est. completion date May 9, 2023

Study information

Verified date January 2024
Source Boryung Pharmaceutical Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 9, 2023
Est. primary completion date May 9, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BR6001-1
One tablet administered alone, Once a day
BR6001-2
One tablet administered alone, Once a day

Locations

Country Name City State
Korea, Republic of ChungBuk National University Hospital Chungbuk

Sponsors (1)

Lead Sponsor Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUCt,ss Area under the Plasma Concentration-Time Curve During Dosing Interval (tau) at Steady State 0~24 hours after administration
Primary Cmax,ss Maximum Concentration of Drug in Plasma at Steady State 0~24 hours after administration
Primary 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
See also
  Status Clinical Trial Phase
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Recruiting NCT01926600 - Sublingual Administration of PPI N/A