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HypertensionPhase 1NCT05097794

A Clinical Trial to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers

A Phase 1 study testing BR1015-1, BR1015-2 and BR1015-1 + BR1015-2 in people with Hypertension, 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 pharmacokinetic interactions (Drug-Drug interaction) and safety between "BR1015-1" and "BR1015-2" in healthy volunteers. Read more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
BR1015-1, BR1015-2 and BR1015-1 + BR1015-2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteSouth Korea
Study dates
16 Aug 2021to 22 Oct 2021
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

  • Subjects are given sufficient explanations about the trial objectives and contents as well as properties of investigational drugs before participating in the trial, and will voluntarily express their consent by signing an IRB-approved written consent to participate in the trial.
  • Healthy adults aged 19 to 55 years at screening.
  • The subject's weight is 50 kg or more for males, 45 kg or more for females, and body mass index (BMI) is 18.0 or more but 30.0 kg/m2 or less.

Who cannot join

  • Those who have history of clinically significant diseases including hypersensitivity reaction, intolerability and anaphylaxis to major ingredients and other ingredients of investigational products.
  • Those who have history of clinically significant diseases including allergy reaction to Yellow No. 5 (Sunset Yellow FCF).
  • Those who have a history of clinically significant diseases related to liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system, cardiovascular system (including orthostatic hypotension), etc.
  • Those who have medical history of gastrointestinal system diseases (for example: Crohn's disease, peptic ulcer disease, etc.) and operations that may influence the absorption of investigational drugs. (However, appendectomy, hernia operation, endoscopic polypectomy and hemorrhoids/anal fissure/anal fistula surgeries are excluded.)
  • Those with abnormal findings from the screening tests (medical interview, vital signs, electrocardiography, physical checkup, blood test, urinalysis, etc.) are judged to have clinical significance.
  • Those who are positive to HBsAg, HCV Ab, HIV Ab, VDRL tests at screening.
Show all 14Show fewer
  • Those with any of the following results at screening:
  • AST or ALT > twice the upper limit of normal range
  • T. bilirubin > twice the upper limit of normal range
  • Estimated glomerular filtration rate (e-GFR) < 60 mL/min/1.73m2 (CKD-EPI method used)
  • Na > 150 mEq/L or <130 mEq/L
  • K > 5.5 mEq/L or <3.0 mEq/L
  • Those with systolic blood pressure > 160 mmHg or < 110 mmHg, or diastolic blood pressure > 100 mmHg or < 70 mmHg from vital signs at screening.
  • Others who are judged to be ineligible to participate in the trial by the investigator.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • CHA Bundang Medical Center, CHA University

    Gyeonggi-do, Seongnam-si, 13520

Other trials in South Korea

About this study

Official title: An Open-label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers.

The purpose of this study is to evaluate pharmacokinetic interactions (Drug-Drug interaction) and safety between "BR1015-1" and "BR1015-2" in healthy volunteers.

Read the detailed description

*Study Objective: After repeated administration of BR1015-1 and BR1015-2 for healthy volunteers, the pharmacokinetic interactions and safety are evaluated.

*Investigational Product (and regimen)

  1. BR1015-1: Administration of BR1015-1 60 mg once a day for 5 days
  2. BR1015-2: Administration of BR1015-2 1.5 mg once a day for 5 days
  3. BR1015-1+BR1015-2: Co-administration of BR1015-1 60 mg and BR1015-2 1.5 mg once a day for 5 days
Conditions
Hypertension
Being tested
BR1015-1, BR1015-2, BR1015-1 + BR1015-2
Medical subject headings
Hypertension

What participants receive

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

  • BR1015-1Drug

    Also called Fimasartan 60 mg

    • Administration to the BR1015-1 group: 60 mg of BR1015-1 will be administered one tablet once a day, five-day repeated doses.

  • BR1015-2Drug

    Also called Indapamide 1.5 mg

    • Administration to the BR1015-2 group: 1.5 mg of BR1015-2 will be administered one tablet once a day, five-day repeated doses.

  • BR1015-1 + BR1015-2Drug

    Also called Fimasartan and Indapamide

    • Co-administration to the BR1015-1+BR1015-2 group: 60 mg of BR1015-1 one tablet and 1.5 mg of BR1015-2 one tablet will be co-administered once a day, five-day repeated doses.
Study groups in NCT05097794
Study groupRoleWhat they receive
Sequence BR1015-1/BR1015-2/BR1015-1 + BR1015-2ExperimentalA total of 32 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(BR1015-1, BR1015-2, BR1015-1 + BR1015-2) assigned to one sequence group in Period 1, Period 2, and Period 3. * Period 1(BR1015-1): BR1015-1(Fimasartan 60mg) - 1 tablet QD, five-day repeated-dose * Period 2(BR1015-2): BR1015-2(Indapamide 1.5mg) - 1 tablet QD, five-day repeated-dose * Period 3(BR1015-1 + BR1015-2): BR1015-1 (Fimasartan 60mg) 1 tablet + BR1015-2 (Indapamide 1.5mg) 1 tablet QD, five-day repeated-dose * Washout period between Period 1 and Period 2: five days * Washout period between Period 2 and Period 3: two days
Receives: Drug: BR1015-1; Drug: BR1015-2; Drug: BR1015-1 + BR1015-2

What is being measured

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

  1. [Part A] Cmax,ss of BR1015-1

    Pharmacokinetic variables - Maximum (peak) plasma concentration of BR1015-1 at steady state (Cmax,ss).

    Measured: 0~24 hour after administration at Day 5.

  2. [Part B] Cmax,ss of BR1015-2

    Pharmacokinetic variables - Maximum (peak) plasma concentration of BR1015-2 at steady state (Cmax,ss).

    Measured: 0~24 hour after administration at Day 5.

  3. [Part A] AUCtau of BR1015-1

    Pharmacokinetic variables - Area under the plasma drug concentration-time curve to the end of the dosing period in multiple dosing of BR1015-1 at steady state. (AUCtau,ss)

    Measured: 0~24 hour after administration at Day 5.

  4. [Part B] AUCtau of BR1015-2

    Pharmacokinetic variables - Area under the plasma drug concentration-time curve to the end of the dosing period in multiple dosing of BR1015-2 at steady state. (AUCtau,ss)

    Measured: 0~24 hour after administration at Day 5.

Secondary outcomes (8)

  1. [Part A] AUClast of BR1015-1

    Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUClast) of BR1015-1

    Measured: 0~48 hour after administration

  2. [Part B] AUClast of BR1015-2

    Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUClast) of BR1015-2

    Measured: 0~48 hour after administration

  3. [Part A] AUCinf of BR1015-1

    Area under the plasma drug concentration-time curve over the time interval from 0 extrapolated to infinity of BR1015-1

    Measured: 0~48 hour after administration

  4. [Part B] AUCinf of BR1015-2

    Area under the plasma drug concentration-time curve over the time interval from 0 extrapolated to infinity of BR1015-2

    Measured: 0~48 hour after administration

  5. [Part A] Tmax of BR1015-1

    Time to reach maximum (peak) plasma concentration following drug administration at steady state (Tmax,ss)

    Measured: 0~24 hour after administration

  6. [Part B] Tmax of BR1015-2

    Time to reach maximum (peak) plasma concentration following drug administration at steady state (Tmax,ss)

    Measured: 0~24 hour after administration

  7. [Part A] t1/2 of BR1015-1

    Terminal half-life of BR1015-1

    Measured: 0~48 hour after administration

  8. [Part B] t1/2 of BR1015-2

    Terminal half-life of BR1015-2

    Measured: 0~48 hour after administration

Timeline

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

  1. First posted28 Oct 2021
  2. Study start16 Aug 2021
  3. Primary completion22 Oct 2021
  4. Study completion22 Oct 2021

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
One-sequence, 3-period study.
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05097794
Sponsor's protocol ID
BR-FMS-CT-118
Status last verified
Oct 2021
First submitted
17 Oct 2021
Last updated
22 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BR1015-1, BR1015-2 and BR1015-1 + BR1015-2 in people with Hypertension, 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 3 inclusion and 14 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 22 Nov 2021. 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?

[Part A] Cmax,ss of BR1015-1 (time frame: 0~24 hour after administration at Day 5.). The study lists 4 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 NCT05097794.

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 22 Nov 2021.

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