A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-1" and "BR1019-2"

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Open-label, Single Dose, Two-way Replicate Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-1" and "BR1019-2" in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06226727
• Other study ID #: BR-FDC-CT-103
• Status: Completed
• Phase: Phase 1
• Start date: February 14, 2024
• Est. completion date: March 31, 2024

Study information

• Verified date: April 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 evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-1" and "BR1019-2" in healthy volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 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 decide to voluntarily participate after listening to and understanding the detailed explanation of this clinical trial and who sign a written consent to comply with the subject's precautions during this clinical trial.

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 ETC, OTC, Oriental medicine, Health functional food 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 bioequivalence tests or other clinical trials 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 gastrectomy(Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
• Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or its products, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
• In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Essential Hypertension
• Type 2 Diabetes Mellitus

Intervention

Drug:
• BR1019
One tablet administered alone
• BR1019-1
One tablet administered alone
• BR1019-2
One tablet administered alone

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 concentration-time curve from time zero to time t	0-48 hours after administration
Primary	Cmax	Maximum concentration of drug in plasma	0-48 hours after administration