A Study to Evaluate the Pharmacokinetics and Safety of BR3409 and Co-administration of BR3409-1 and BR3409-2 in Healthy Volunteers Under Fasting Conditions

NCT06879158 | Completed Phase 1

• 1 other identifier: BR-ELMC-CT-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate the pharmacokinetics and safety of BR3409 and co-administration of BR3409-1 and BR3409-2 in healthy volunteers Under Fasting Conditions

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• AUCτ

  Area under the plasma drug concentration-time curve from 0 to time τ

  0~72 hours after administration

• Cmax

  Maximum Concentration of Drug in Plasma

  0~72 hours after administration

Study Arms (2)

BR3409

EXPERIMENTAL

Drug: BR3409

BR3409-1 + BR3409-2

ACTIVE COMPARATOR

Drug: BR3409-1; Drug: BR3409-2

Interventions

BR3409 DRUG

One tablet administered alone

BR3409

BR3409-1 DRUG

One tablet administered alone

BR3409-1 + BR3409-2

BR3409-2 DRUG

One tablet administered alone

BR3409-1 + BR3409-2

Eligibility Criteria

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

You may qualify if:

• Those have body mass index (BMI: weight(kg)/the square of {height(m)}) within the range of 18.0 to 30.0 at screening visit.
• For men, Those who weigh 55 kg or more
• For women, Those who weigh 50 kg or more
• 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\*(Except for hormone drugs) from the date of consent to 56 days after the last administration and disagree 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.

You may not qualify if:

• Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days before the first administration date or have taken drugs concerned about affecting this clinical trial within 10 days before the first administration date. (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 other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before the first day of administration. (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 resection 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 or 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

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System 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: March 11, 2025
• First Posted: March 17, 2025
• Study Start: November 10, 2024
• Primary Completion: January 26, 2025
• Study Completion: January 26, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)