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 Fasting Conditions in Healthy Adult Volunteers

NCT06289920 | Completed Phase 1

• 1 other identifier: BR-EMC-CT-102
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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 fasting conditions in healthy adult volunteers

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• AUCτ

  Area under the Plasma Concentration-Time Curve During a Dosing Interval (tau)

  0~48 hours after administration

• Cmax

  Maximum Concentration of Drug in Plasma

  0~48 hours after administration

Study Arms (2)

BR3005

EXPERIMENTAL

Drug: BR3005

BR3005-1+BR3005-2

ACTIVE COMPARATOR

Drug: BR3005-1; Drug: BR3005-2

Interventions

BR3005 DRUG

One tablet administered alone, Once a day

BR3005

BR3005-1 DRUG

One tablet administered alone, Once a day

BR3005-1+BR3005-2

BR3005-2 DRUG

One tablet administered alone, Once a day

BR3005-1+BR3005-2

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 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 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.

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: February 26, 2024
• First Posted: March 4, 2024
• Study Start: March 2, 2024
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)