A Study to Evaluate the Pharmacokinetic, Pharmacodynamic Characteristics and the Safety After Administration by Doses of BR1400-1, BR1400-2, BR1400-3 in Healthy Adult Volunteers

A Randomized, Open-label, Single Oral Dose, Three-arm, Parallel Design, Phase 1 Study to Evaluate the Pharmacokinetic, Pharmacodynamic Characteristics and the Safety After Administration by Doses of BR1400-1, BR1400-2, BR1400-3 in Healthy Volunteers

The purpose of this clinical study is to evaluate the pharmacokinetic, pharmacodynamic characteristics and the safety after administration by doses of "BR1400-1", "BR1400-2", "BR1400-3" in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: BR1400-1; Drug: BR1400-2; Drug: BR1400-3

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul Bumin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Those who have body mass index (BMI) of 18.0kg/m2 to 30.0kg/m2 at screening visit.

  • For men, Those who weigh 50 kg or more
  • For women, Those who weigh 45 kg or more

• Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial* from the date of consent to 7 days after the last administration and disagree to provide their sperm or ovum.

  • Methods of contraception accepted in clinical trial: Combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.
• Those who spontaneously decide to participate and sign written consent to observe the subject's compliance during this clinical trial after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.

Exclusion Criteria:

• Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken ethical drugs, over the counter drugs, herbal medicines, health functional foods concerned about affecting this clinical trial within 10 days before the first administration date. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
• Those who have participated in bioequivalence tests or other clinical trials and administered their investigational products within 6 months before the first administration date(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
• Those who have a medical history of gastrointestinal diseases (ex. crohn's disease, ulcerative colitis, etc.) or gastrointestinal resection (Except for simple appendectomy, hernia surgery) that may affect the absorption of drugs or have gastrointestinal diseases
• Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours before the first administration date
• In the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BR1400-1	Drug: BR1400-1; One tablet administered alone
Experimental: BR1400-2	Drug: BR1400-2; One tablet administered alone
Experimental: BR1400-3	Drug: BR1400-3; One tablet administered alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum concentration of drug in plasma	0-48 hours after administration
AUCt	Area under the plasma drug concentration-time curve from 0 to time t	0-48 hours after administration

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2024
• Primary Completion (Actual): October 8, 2024
• Study Completion (Actual): October 8, 2024

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: BR-FMS-CT-120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No