A Clinical Trial Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects

NCT05875259 | Completed Phase 1

• 1 other identifier: BR-FDC-CT-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic interaction and safety between BR1019-1 and BR1019-2 in healthy adult subjects.

Conditions

Hypertension; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• AUC0-24,ss

  Area under the concentration-time curve from 0 h to 24 h of BR1019-1 and BR1019-2 at steady-state

  0-48 hours after administration

• Cmax,ss

  Maximum concentration of drug in plasma of BR1019-1 and BR1019-2 at steady-state

  0-48 hours after administration

Study Arms (6)

Sequence 1

EXPERIMENTAL

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 1: A-B-C

Drug: BR1019-1; Drug: BR1019-2; Drug: BR1019-1 + BR1019-2

Sequence 2

EXPERIMENTAL

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 2: A-C-B

Drug: BR1019-1; Drug: BR1019-2; Drug: BR1019-1 + BR1019-2

Sequence 3

EXPERIMENTAL

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 3: B-A-C

Drug: BR1019-1; Drug: BR1019-2; Drug: BR1019-1 + BR1019-2

Sequence 4

EXPERIMENTAL

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 4: B-C-A

Drug: BR1019-1; Drug: BR1019-2; Drug: BR1019-1 + BR1019-2

Sequence 5

EXPERIMENTAL

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 5: C-A-B

Drug: BR1019-1; Drug: BR1019-2; Drug: BR1019-1 + BR1019-2

Sequence 6

EXPERIMENTAL

The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. \*sequence 6: C-B-A

Drug: BR1019-1; Drug: BR1019-2; Drug: BR1019-1 + BR1019-2

Interventions

BR1019-1 DRUG

Treatment group A : One tablet of BR1019-1 administered alone once daily for 7 days.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

BR1019-2 DRUG

Treatment group B : One tablet of BR1019-2 administered alone once daily for 7 days.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

BR1019-1 + BR1019-2 DRUG

Treatment group C : One tablet each of BR1019-1 and BR1019-2 administered in combination once daily for 7 days.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

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

You may qualify if:

• Healthy adults aged 19 to 55 years at screening
• Those who voluntarily decide to participate in the study and provide written consent to follow the study directions after listening to and fully understanding the detailed explanation on this study

You may not qualify if:

• Those who have clinically significant diseases associated with the cardiovascular system, respiratory system, liver, kidney, nervous system, endocrine system, blood/tumor, psychiatric disorders, or urinary system, as well as drug abuse, or a history thereof.
• Those who took any prescription drugs or herbal medicines within 14 days prior to the first day of administration or any over-the-counter (OTC) drugs within 7 days prior to the first day of administration (however, if other conditions are appropriate according to the judgment of the investigator, they may participate in the clinical study.)
• Those who took drugs inducing and inhibiting drug-metabolizing enzymes, such as barbiturates, within 30 days prior to the study initiation.
• Those who have been on a diet (especially grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 7 days prior to the first day of administration.
• Pregnant women, potentially pregnant women, or breast-feeding women Those who do not agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using medically acceptable methods of contraception\* throughout the entire period from the date of the first administration of the investigational product to the end of the clinical study
• Medically acceptable methods of contraception: 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 are unwilling or unable to comply with the dietary and lifestyle guidelines required for the clinical study
• Those who have clinically significant abnormalities in the results of other clinical laboratory tests or who have been determined by the investigator to be ineligible to participate in the clinical study due to other reasons (e.g., non-compliance with instructions, uncooperative attitude, etc.)

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; 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: May 11, 2023
• First Posted: May 25, 2023
• Study Start: May 13, 2023
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)