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

Type2 Diabetes Mellitus Clinical Trial

Official title:

An Open Label, Randomized, Fed, Single Dose, 2-sequence, 2-period, Crossover 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" in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06289933
• Other study ID #: BR-EMC-CT-103
• Status: Completed
• Phase: Phase 1
• Start date: March 5, 2024
• Est. completion date: April 3, 2024

Study information

• Verified date: May 2024
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 3, 2024
• Est. primary completion date: April 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Drug:
• BR3005
One tablet administered alone, Once a day
• BR3005-1
One tablet administered alone, Once a day
• BR3005-2
One tablet administered alone, Once a day

Locations

Country	Name	City	State
Korea, Republic of	Clinical Research Center, H PLUS Yangji Hospital	Seoul	Gwanakgu

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt	Area under the Plasma Concentration-Time Curve During a Dosing Interval (tau)	0~48 hours after administration
Primary	Cmax	Maximum Concentration of Drug in Plasma	0~48 hours after administration