A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-1" and "BR1019-2"

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 "BR1019-1" and "BR1019-2" in Healthy Volunteers

The objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-1" and "BR1019-2" in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Essential Hypertension
• Intervention / Treatment: Drug: BR1019; Drug: BR1019-1; Drug: BR1019-2

• 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 who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit

  • In case of a male subject, Those who weigh 50 kg or more
  • In case of a female subject, Those who weigh 45 kg or more
• Those who decide to voluntarily participate after listening to and understanding the detailed explanation of this clinical trial and who sign a written consent to comply with the subject's precautions during this clinical trial.

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 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 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 gastrectomy(Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
• Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or its products, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
• In the case of a female subject, those suspected pregnancy, pregnant woman, 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: Sequence Group A; The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4. *Sequence Group A [Period 1, 3] Co-administration of BR1019-1(R1) and BR1019-2(R2). [Period 2, 4] Administration of BR1019(T)	Drug: BR1019; One tablet administered alone; Drug: BR1019-1; One tablet administered alone; Drug: BR1019-2; One tablet administered alone
Experimental: Sequence Group B; The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4. *Sequence Group B [Period 1, 3] Administration of BR1019(T) [Period 2, 4] Co-administration of BR1019-1(R1) and BR1019-2(R2).	Drug: BR1019; One tablet administered alone; Drug: BR1019-1; One tablet administered alone; Drug: BR1019-2; One tablet administered alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCτ	Area under the concentration-time curve from time zero to time τ	0-48 hours after administration
Cmax	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): February 14, 2024
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypertension; Diabetes Mellitus, Type 2; Essential Hypertension
• Other Study ID Numbers: BR-FDC-CT-103

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