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

NCT ID: NCT06890299

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-05
• Study Completion Date: 2025-01-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BR3006

Group Type: EXPERIMENTAL

BR3006

Intervention Type: DRUG

One tablet administered alone

BR3006A+BR3006B+BR3006C

Group Type: ACTIVE_COMPARATOR

BR3006A

Intervention Type: DRUG

One tablet administered alone

BR3006B

Intervention Type: DRUG

One tablet administered alone

BR3006C

Intervention Type: DRUG

One tablet administered alone

Interventions

BR3006

One tablet administered alone

Intervention Type: DRUG

BR3006A

One tablet administered alone

Intervention Type: DRUG

BR3006B

One tablet administered alone

Intervention Type: DRUG

BR3006C

One tablet administered alone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

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 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Research Center, H PLUS Yangji Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BR-DPMC-CT-103

Identifier Type: -

Identifier Source: org_study_id