A Study to Evaluate the Pharmacokinetics and Safety Between Single Oral Administration of BR3006 and Co-administration of BR3006A, BR3006B and BR3006C in Healthy Adult Volunteers Under Fed Conditions

NCT06890299 | Completed Phase 1

• 1 other identifier: BR-DPMC-CT-103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate the pharmacokinetics and safety between single oral administration of BR3006 and co-administration of BR3006A, BR3006B and BR3006C in healthy adult volunteers under fed conditions

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• AUCt

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

  0-48 hours after administration

• Cmax

  Maximum concentration of drug in plasma

  0-48 hours after administration

Study Arms (2)

BR3006

EXPERIMENTAL

Drug: BR3006

BR3006A+BR3006B+BR3006C

ACTIVE COMPARATOR

Drug: BR3006A; Drug: BR3006B; Drug: BR3006C

Interventions

BR3006 DRUG

One tablet administered alone

BR3006

BR3006A DRUG

One tablet administered alone

BR3006A+BR3006B+BR3006C

BR3006B DRUG

One tablet administered alone

BR3006A+BR3006B+BR3006C

BR3006C DRUG

One tablet administered alone

BR3006A+BR3006B+BR3006C

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) of 18.0kg/m2 to 30.0kg/m2 at screening visit.
• For men, Those who weigh 55 kg or more
• For women, Those who weigh 50 kg or more
• 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 consent to 14 days after the last administration and disagree to provide their sperm or ovum.
• Methods of contraception accepted in clinical trial: Combined use of non hormonal 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.
• 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.

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 ethical drugs, over the counter drugs, herbal medicines, health functional foods 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 a medical history of gastrointestinal resection (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
• Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before the first administration date(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
• In the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Clinical Research Center, H PLUS Yangji Hospital

Seoul, 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 17, 2025
• First Posted: March 24, 2025
• Study Start: December 5, 2024
• Primary Completion: January 12, 2025
• Study Completion: January 12, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)