HypertensionPhase 1NCT05875259

A Clinical Trial Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects

A Phase 1 study testing BR1019-1, BR1019-2 and BR1019-1 + BR1019-2 in people with Hypertension and Diabetes Mellitus, Type 2, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the pharmacokinetic interaction and safety between BR1019-1 and BR1019-2 in healthy adult subjects. Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension, Diabetes Mellitus, Type 2
What is being tested?: BR1019-1, BR1019-2 and BR1019-1 + BR1019-2
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteSouth Korea
Study dates: 13 May 2023to 29 Jun 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults aged 19 to 55 years at screening
Those who voluntarily decide to participate in the study and provide written consent to follow the study directions after listening to and fully understanding the detailed explanation on this study

Who cannot join

Those who have clinically significant diseases associated with the cardiovascular system, respiratory system, liver, kidney, nervous system, endocrine system, blood/tumor, psychiatric disorders, or urinary system, as well as drug abuse, or a history thereof.
Those who took any prescription drugs or herbal medicines within 14 days prior to the first day of administration or any over-the-counter (OTC) drugs within 7 days prior to the first day of administration (however, if other conditions are appropriate according to the judgment of the investigator, they may participate in the clinical study.)
Those who took drugs inducing and inhibiting drug-metabolizing enzymes, such as barbiturates, within 30 days prior to the study initiation.
Those who have been on a diet (especially grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 7 days prior to the first day of administration.
Pregnant women, potentially pregnant women, or breast-feeding women Those who do not agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using medically acceptable methods of contraception* throughout the entire period from the date of the first administration of the investigational product to the end of the clinical study
Medically acceptable methods of contraception: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used
Those who are unwilling or unable to comply with the dietary and lifestyle guidelines required for the clinical study
Those who have clinically significant abnormalities in the results of other clinical laboratory tests or who have been determined by the investigator to be ineligible to participate in the clinical study due to other reasons (e.g., non-compliance with instructions, uncooperative attitude, etc.)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Inha University Hospital
Incheon

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple-dose, 6-sequence, 3-treatment, 3-period, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects

The purpose of this study is to evaluate the pharmacokinetic interaction and safety between BR1019-1 and BR1019-2 in healthy adult subjects.

Conditions: Hypertension, Diabetes Mellitus, Type 2
Being tested: BR1019-1, BR1019-2, BR1019-1 + BR1019-2
Medical subject headings: Hypertension, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BR1019-1Drug
Treatment group A : One tablet of BR1019-1 administered alone once daily for 7 days.
BR1019-2Drug
Treatment group B : One tablet of BR1019-2 administered alone once daily for 7 days.
BR1019-1 + BR1019-2Drug
Treatment group C : One tablet each of BR1019-1 and BR1019-2 administered in combination once daily for 7 days.

Study groups in NCT05875259
Study group	Role	What they receive
Sequence 1	Experimental	The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. *sequence 1: A-B-C Receives: Drug: BR1019-1; Drug: BR1019-2; Drug: BR1019-1 + BR1019-2
Sequence 2	Experimental	The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. *sequence 2: A-C-B Receives: Drug: BR1019-1; Drug: BR1019-2; Drug: BR1019-1 + BR1019-2
Sequence 3	Experimental	The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. *sequence 3: B-A-C Receives: Drug: BR1019-1; Drug: BR1019-2; Drug: BR1019-1 + BR1019-2
Sequence 4	Experimental	The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. *sequence 4: B-C-A Receives: Drug: BR1019-1; Drug: BR1019-2; Drug: BR1019-1 + BR1019-2
Sequence 5	Experimental	The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. *sequence 5: C-A-B Receives: Drug: BR1019-1; Drug: BR1019-2; Drug: BR1019-1 + BR1019-2
Sequence 6	Experimental	The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. *sequence 6: C-B-A Receives: Drug: BR1019-1; Drug: BR1019-2; Drug: BR1019-1 + BR1019-2

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC0-24,ss
Area under the concentration-time curve from 0 h to 24 h of BR1019-1 and BR1019-2 at steady-state
Measured: 0-48 hours after administration
Cmax,ss
Maximum concentration of drug in plasma of BR1019-1 and BR1019-2 at steady-state
Measured: 0-48 hours after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 202329 Jun 2023

First posted25 May 2023
Study start13 May 2023
Primary completion29 Jun 2023
Study completion29 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05875259
Sponsor's protocol ID: BR-FDC-CT-101
Status last verified: Sep 2023
First submitted: 11 May 2023
Last updated: 28 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Multiple-dose, 6-sequence, 3-treatment, 3-period, Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT05875259
Acronym / sponsor ID: BR-FDC-CT-101
Conditions: Hypertension, Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: 13 May 2023 (actual)
Primary completion: 29 Jun 2023 (actual)
Study completion: 29 Jun 2023 (actual)
First posted: 25 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the pharmacokinetic interaction and safety between BR1019-1 and BR1019-2 in healthy adult subjects.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1	Experimental	Drug: BR1019-1, Drug: BR1019-2, Drug: BR1019-1 + BR1019-2The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. *sequence 1: A-B-C
Sequence 2	Experimental	Drug: BR1019-1, Drug: BR1019-2, Drug: BR1019-1 + BR1019-2The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. *sequence 2: A-C-B
Sequence 3	Experimental	Drug: BR1019-1, Drug: BR1019-2, Drug: BR1019-1 + BR1019-2The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. *sequence 3: B-A-C
Sequence 4	Experimental	Drug: BR1019-1, Drug: BR1019-2, Drug: BR1019-1 + BR1019-2The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. *sequence 4: B-C-A
Sequence 5	Experimental	Drug: BR1019-1, Drug: BR1019-2, Drug: BR1019-1 + BR1019-2The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. *sequence 5: C-A-B
Sequence 6	Experimental	Drug: BR1019-1, Drug: BR1019-2, Drug: BR1019-1 + BR1019-2The Investigational products will be administered according to the treatment groups(A,B,C) assigned to each sequence group in Period 1, Period 2, and Period 3. *sequence 6: C-B-A

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy adults aged 19 to 55 years at screening
Those who voluntarily decide to participate in the study and provide written consent to follow the study directions after listening to and fully understanding the detailed explanation on this study

Key exclusion criteria (8 listed)

Those who have clinically significant diseases associated with the cardiovascular system, respiratory system, liver, kidney, nervous system, endocrine system, blood/tumor, psychiatric disorders, or urinary system, as well as drug abuse, or a history thereof.
Those who took any prescription drugs or herbal medicines within 14 days prior to the first day of administration or any over-the-counter (OTC) drugs within 7 days prior to the first day of administration (however, if other conditions are appropriate according to the judgment of the investigator, they may participate in the clinical study.)
Those who took drugs inducing and inhibiting drug-metabolizing enzymes, such as barbiturates, within 30 days prior to the study initiation.
Those who have been on a diet (especially grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 7 days prior to the first day of administration.
Pregnant women, potentially pregnant women, or breast-feeding women Those who do not agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using medically acceptable methods of contraception* throughout the entire period from the date of the first administration of the investigational product to the end of the clinical study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BR1019-1Treatment group A : One tablet of BR1019-1 administered alone once daily for 7 days.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
BR1019-2Treatment group B : One tablet of BR1019-2 administered alone once daily for 7 days.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
BR1019-1 + BR1019-2Treatment group C : One tablet each of BR1019-1 and BR1019-2 administered in combination once daily for 7 days.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6

Primary outcome

AUC0-24,ss
Time frame: 0-48 hours after administration
Area under the concentration-time curve from 0 h to 24 h of BR1019-1 and BR1019-2 at steady-state
Cmax,ss
Time frame: 0-48 hours after administration
Maximum concentration of drug in plasma of BR1019-1 and BR1019-2 at steady-state

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Individual participant dataSharing planned: No

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Chronic Kidney Disease, Hypertension (HTN)
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BR1019-1, BR1019-2 and BR1019-1 + BR1019-2 in people with Hypertension and Diabetes Mellitus, Type 2, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-24,ss (time frame: 0-48 hours after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05875259.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.