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

NCT06226727 | Completed Phase 1

• 1 other identifier: BR-FDC-CT-103
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus; Essential Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sequence Group A

EXPERIMENTAL

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; Drug: BR1019-1; Drug: BR1019-2

Sequence Group B

EXPERIMENTAL

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; Drug: BR1019-1; Drug: BR1019-2

Interventions

BR1019 DRUG

One tablet administered alone

Sequence Group A; Sequence Group B

BR1019-1 DRUG

One tablet administered alone

Sequence Group A; Sequence Group B

BR1019-2 DRUG

One tablet administered alone

Sequence Group A; Sequence Group B

Eligibility Criteria

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

You may qualify if:

• 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.

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 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.

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

Diabetes Mellitus, Type 2; Essential Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; 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: January 18, 2024
• First Posted: January 26, 2024
• Study Start: February 14, 2024
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)