A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-3" and "BR1019-2" in Healthy Volunteers

A Randomized, Open-label, Single Dose, Two-way Replicate Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-3" and "BR1019-2" in Healthy Volunteers

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-3" and "BR1019-2" in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Essential Hypertension
• Intervention / Treatment: Drug: BR1019; Drug: BR1019-2; Drug: BR1019-3

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwanakgu
    • Seoul, Gwanakgu, Korea, Republic of, 08779
      • Clinical Research Center, H PLUS Yangji Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Those have body mass index (BMI) within the range of 18.0 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 spontaneously decide to participate and sign written consent to comply with the subject's precautions during the clinical trial period after listening to and fully understanding detailed explanation of this clinical trial

• 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*(Except for hormone drugs) from the date of the first administration of the investigational products to 7 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, contraceptive 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 ETC, OTC, Oriental medicine, health functional food concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetic and pharmacodynamic properties such as Interaction of investigational products, half-life)
• Those who have participated in bioequivalence tests or other clinical trials 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 (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
• In the case of a female subject, pregnant woman, those suspected pregnancy or lactating woman.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BR1019	Drug: BR1019; One tablet administered alone
Active Comparator: BR1019-2 + BR1019-3	Drug: BR1019-2; One tablet administered alone; Drug: BR1019-3; One tablet administered alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve from time zero to time τ	0-48 hours after administration
Maximum concentration of drug in plasma	0-48 hours after administration

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2024
• Primary Completion (Actual): December 11, 2024
• Study Completion (Actual): December 11, 2024

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: BR-FDC-CT-102

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