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

Hypertension Clinical Trial

Official title:

A Randomized, Open-label, Multiple-dose, 6-sequence, 3-treatment, 3-period, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05875259
• Other study ID #: BR-FDC-CT-101
• Status: Completed
• Phase: Phase 1
• Start date: May 13, 2023
• Est. completion date: June 29, 2023

Study information

• Verified date: September 2023
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 29, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Drug:
• BR1019-1
Treatment group A : One tablet of BR1019-1 administered alone once daily for 7 days.
• BR1019-2
Treatment group B : One tablet of BR1019-2 administered alone once daily for 7 days.
• BR1019-1 + BR1019-2
Treatment group C : One tablet each of BR1019-1 and BR1019-2 administered in combination once daily for 7 days.

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

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	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
Primary	Cmax,ss	Maximum concentration of drug in plasma of BR1019-1 and BR1019-2 at steady-state	0-48 hours after administration