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The purpose of this clinical trial is to evaluate drug-drug interactions and safety between "BR3006-1", "BR3006-2", and "BR3006-3" in healthy volunteers
A total of 36 subjects will be randomized into 6 sequence groups, 6 subjects per sequence group. The Investigational Products wil be according to the treatment group (A,B,C,D,E,F) assigned to each sequence group in Period 1, Period 2 and Period 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1(T1) | Active Comparator | BR3006-1 + BR3006-2 administered in combination once daily for 7 days. |
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| Treatment 2(T2) | Active Comparator | BR3006-3 administered alone once daily for 7 days. |
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| Treatment 3(T3) | Experimental | BR3006-1 + BR3006-2 + BR3006-3 administered in combination once daily for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR3006-1 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss | Area under the concentration-time curve from time zero to time Ï„ of BR3006-1, BR3006-2 and BR3006-3 at steady-state | Day 1 (0h), Day 5 (0h), Day 6 (0h), Day 7 (0h~14h) & Day 8 (0h), Day 9 (0h), Day 10 (0h) of each period |
| Cmax,ss | Maximum concentration of drug in plasma of BR3006-1, BR3006-2 and BR3006-3 at steady-state | Day 1 (0h), Day 5 (0h), Day 6 (0h), Day 7 (0h~14h) & Day 8 (0h), Day 9 (0h), Day 10 (0h) of each period |
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Inclusion Criteria:
Exclusion Criteria:
Those who have clinically significant diseases associated with the liver, kidney, gastrointestinal system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, blood/tumor system, cardiovascular system, severe infection, severe traumatic systemic disorder, etc.
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
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center(CBMC) | Seongnam-si | Gyeonggi-do | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| BR3006-2 | Drug | 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. |
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| BR3006-3 | Drug | 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. |
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