A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fed Conditions in Healthy Adult Volunteers

NCT ID: NCT06289933

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2024-04-03

Brief Summary

The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fed conditions in healthy adult volunteers

Conditions

Type2 Diabetes Mellitus

Study Design

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

Study Groups

BR3005

Group Type: EXPERIMENTAL

BR3005

Intervention Type: DRUG

One tablet administered alone, Once a day

BR3005-1+BR3005-2

Group Type: ACTIVE_COMPARATOR

BR3005-1

Intervention Type: DRUG

One tablet administered alone, Once a day

BR3005-2

Intervention Type: DRUG

One tablet administered alone, Once a day

Interventions

BR3005

One tablet administered alone, Once a day

Intervention Type: DRUG

BR3005-1

One tablet administered alone, Once a day

Intervention Type: DRUG

BR3005-2

One tablet administered alone, Once a day

Intervention Type: DRUG

Eligibility Criteria

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 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 drugs 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 other clinical trials(including bioequivalence tests) and 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 gastrointestinal surgery 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, pregnant woman, 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, Gwanakgu, South Korea

Countries

South Korea

Other Identifiers

BR-EMC-CT-103

Identifier Type: -

Identifier Source: org_study_id