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

NCT ID: NCT06889064

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-24
• Study Completion Date: 2024-10-08

Brief Summary

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

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BR1400-1

Group Type: EXPERIMENTAL

BR1400-1

Intervention Type: DRUG

One tablet administered alone

BR1400-2

Group Type: EXPERIMENTAL

BR1400-2

Intervention Type: DRUG

One tablet administered alone

BR1400-3

Group Type: EXPERIMENTAL

BR1400-3

Intervention Type: DRUG

One tablet administered alone

Interventions

BR1400-1

One tablet administered alone

Intervention Type: DRUG

BR1400-2

One tablet administered alone

Intervention Type: DRUG

BR1400-3

One tablet administered alone

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul Bumin Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BR-FMS-CT-120

Identifier Type: -

Identifier Source: org_study_id