A Study to Evaluate Drug-drug Interactions and Safety Between "BR3006-1", "BR3006-2", and "BR3006-3" in Healthy Volunteers
NCT ID: NCT05951946
Last Updated: 2023-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2023-07-22
2023-09-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment 1(T1)
BR3006-1 + BR3006-2 administered in combination once daily for 7 days.
BR3006-1
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
BR3006-2
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
Treatment 2(T2)
BR3006-3 administered alone once daily for 7 days.
BR3006-3
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
Treatment 3(T3)
BR3006-1 + BR3006-2 + BR3006-3 administered in combination once daily for 7 days.
BR3006-1
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
BR3006-2
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
BR3006-3
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
Interventions
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BR3006-1
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
BR3006-2
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
BR3006-3
All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
Eligibility Criteria
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Inclusion Criteria
* Those who voluntarily decide to participate in the study after listening to and fully understanding the detailed explanation of this study and provide written consent prior to the screening procedure.
Exclusion Criteria
* Those who have a medical history of gastrointestinal diseases (e.g., Crohn's disease, ulcerative disease, etc.) or gastrointestinal surgery (however, appendectomy, hernia surgery, endoscopic polyp surgery, hemorrhoids•anal fissure•anal fistula surgery are excluded) that may affect the absorption of drugs.
* Those who have participated in another clinical study within 180 days prior to the first administration date.(However, the termination criteria for participation in previous clinical trials is counted as one day after the date of the last administration)
* Those who take any prescription drugs(including herbal medicines) or any over-the-counter (OTC) drugs within 14 days prior to the first day of administration or who disagree with the prohibition about taking it from within 14 days prior to the first day of administration to the end of the study (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 have taken a food (e.g., grapefruit juice, etc.) or health functional foods that may affect the absorption, distribution, metabolism, and excretion of the drug within 3 days prior to the first day of administration or cannot stop taking it from within 3 days prior to the first day of administration to the end of the study.
* Those who do not agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception (except for hormone drugs) accepted in clinical trial from the date of the first administration of the investigational product to 7 days after the last administration or disagrees to provide their sperm or ovum
* Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used
* Those who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
* Pregnant women, breast-feeding women or those positive in a pregnancy test.
19 Years
55 Years
ALL
Yes
Sponsors
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Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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CHA Bundang Medical Center(CBMC)
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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BR-DPMC-CT-101
Identifier Type: -
Identifier Source: org_study_id
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