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

Gastric or Duodenal Ulcer Clinical Trial

Official title:

A Phase I Clinical Trial to Evaluate the Drug-drug Interaction and Safety Between "BR6001-1" and "BR6001-2" in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06165237
• Other study ID #: BR-ARC-CT-101
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Duodenal Ulcer
• Gastric or Duodenal Ulcer

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