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

NCT06008028 | Completed Phase 1

• 1 other identifier: BR-FIC-CT-101
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• AUCτ

  Area under the concentration-time curve from time zero to time τ

  0-72 hours after administration

• Cmax

  Maximum concentration of drug in plasma

  0-72 hours after administration

Study Arms (2)

BR1015

EXPERIMENTAL

Drug: BR1015

BR1015-1 + BR1015-2

ACTIVE COMPARATOR

Drug: BR1015-1; Drug: BR1015-2

Interventions

BR1015 DRUG

One tablet administered alone

BR1015

BR1015-1 DRUG

One tablet administered alone

BR1015-1 + BR1015-2

BR1015-2 DRUG

One tablet administered alone

BR1015-1 + BR1015-2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Clinical Research Center, H PLUS Yangji Hospital

Seoul, Gwanakgu, 08779, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular 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: August 16, 2023
• First Posted: August 23, 2023
• Study Start: August 10, 2023
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)