A Study to Evaluate Drug-drug Interactions and Safety Between "BR3006-1", "BR3006-2", and "BR3006-3" in Healthy Volunteers

NCT05951946 | Completed Phase 1

• 1 other identifier: BR-DPMC-CT-101
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• AUCτ,ss

  Area under the concentration-time curve from time zero to time τ 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

Study Arms (3)

Treatment 1(T1)

ACTIVE COMPARATOR

BR3006-1 + BR3006-2 administered in combination once daily for 7 days.

Drug: BR3006-1; Drug: BR3006-2

Treatment 2(T2)

ACTIVE COMPARATOR

BR3006-3 administered alone once daily for 7 days.

Drug: BR3006-3

Treatment 3(T3)

EXPERIMENTAL

BR3006-1 + BR3006-2 + BR3006-3 administered in combination once daily for 7 days.

Drug: BR3006-1; Drug: BR3006-2; Drug: BR3006-3

Interventions

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.

Treatment 1(T1); Treatment 3(T3)

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.

Treatment 1(T1); Treatment 3(T3)

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.

Treatment 2(T2); Treatment 3(T3)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• At the time of screening test, those who weigh 55 kg or more for men and 50 kg or more for women and have body mass index (BMI) within the range of 18.5 to 30.0 kg/m2.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

CHA Bundang Medical Center(CBMC)

Seongnam-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 19, 2023
• Study Start: July 22, 2023
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)