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A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-3" and "BR1019-2" in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-3" and "BR1019-2" in Healthy Volunteers

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 "BR1019-3" and "BR1019-2" in Healthy Volunteers

NCT06636877•Boryung Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-3" and "BR1019-2" in healthy volunteers

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Those have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
•* For men, Those who weigh 50 kg or more
•* For women, Those who weigh 45 kg or more
•Those who spontaneously decide to participate and sign written consent to comply with the subject's precautions during the clinical trial period after listening to and fully understanding detailed explanation of this clinical trial
•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\*(Except for hormone drugs) from the date of the first administration of the investigational products to 7 days after the last administration and disagrees to provide their sperm or ovum.
•* Methods of contraception accepted in clinical trial: Combined use of 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.

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 pharmacokinetic and pharmacodynamic properties such as Interaction of investigational products, half-life)
•Those who have participated in bioequivalence tests or other clinical trials 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 (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
•In the case of a female subject, pregnant woman, those suspected pregnancy or lactating woman.

Locations (1)

Clinical Research Center, H PLUS Yangji Hospital

Seoul, Gwanakgu, South Korea

Key Dates

Start Date

October 23, 2024

Primary Completion Date

December 11, 2024

Completion Date

December 11, 2024

Last Updated

December 13, 2024

Enrollment

ACTUAL participants

Conditions

Essential HypertensionType 2 Diabetes

Interventions

BR1019

DRUG

BR1019-2

DRUG

BR1019-3

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-3" and "BR1019-2" in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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