A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fasting Conditions in Healthy Volunteers

NCT ID: NCT06008028

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2023-10-06

Brief Summary

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of "BR1015" and co-administration of "BR1015-1" and "BR1015-2" under fasting conditions in healthy volunteers

Conditions

Hypertension

Study Design

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

Study Groups

BR1015

Group Type: EXPERIMENTAL

BR1015

Intervention Type: DRUG

One tablet administered alone

BR1015-1 + BR1015-2

Group Type: ACTIVE_COMPARATOR

BR1015-1

Intervention Type: DRUG

One tablet administered alone

BR1015-2

Intervention Type: DRUG

One tablet administered alone

Interventions

BR1015

One tablet administered alone

Intervention Type: DRUG

BR1015-1

One tablet administered alone

Intervention Type: DRUG

BR1015-2

One tablet administered alone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
• Those who sign written consent spontaneously 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.
• 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 the first administration of the investigational products to 14 days after the last administration and 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.

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 drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs)
• Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to 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 surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
• In the case of a female subject, those suspected pregnancy, pregnant woman, 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

Clinical Research Center, H PLUS Yangji Hospital

Seoul, Gwanakgu, South Korea

Countries

South Korea

Other Identifiers

BR-FIC-CT-101

Identifier Type: -

Identifier Source: org_study_id