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HypertensionPhase 1NCT05372380

A Study to Evaluate Drug-drug Interactions Between BR1017-1 and BR1017-2 in Healthy Volunteers

A Phase 1 study testing BR1017-1 and BR1017-2 in people with Hypertension and Hypercholesterinemia, 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

To evaluate the influence of BR1017-1 and BR1017-2 on pharmacokinetics and safety when administered separately or co-administered to 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, Hypercholesterinemia
What is being tested?
BR1017-1 and BR1017-2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSouth Korea
Study dates
9 May 2022to 30 Jun 2022
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

  • Health adults aged 19 to 55 at screening.
  • Male adults whose weight is ≥50kg and female adults whose weight is ≥45kg, and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2 BMI (kg/m2) = weight (kg) / [height (m)]2
  • Those who are given detailed explanations about the trial and express their voluntary consent to participate in the trial by signing a written consent before screening procedure begins.

Who cannot join

  • Those who have history of clinically significant diseases including hypersensitivity reaction, intolerability and anaphylaxis to major ingredients and other ingredients of the investigational products.
  • Those who have history of clinically significant diseases related to liver (including severe hepatopathy), kidney (including severe renal impairment), digestive system (including pancreatitis), respiratory system, musculoskeletal system, endocrine system (patients with diabetic ketoacidosis, diabetic coma and precoma, type 1 diabetes, etc.), neuropsychiatric system, hemato-oncology system, cardiovascular system (including heart failure and orthostatic hypotension), etc.
  • Those who have medical history of gastrointestinal system diseases (for example: Crohn's disease, peptic ulcer disease, etc.) or operations that may influence the absorption of investigational products. (However, appendectomy, hernia operation, endoscopic polypectomy and hemorrhoids/anal fissure/anal fistula surgeries are excluded.)
  • Those who are judged unfit for the trial at screening as follows:
  • Serum ALT, AST and total bilirubin > twice the upper limit of normal levels
  • e-GFR < 60 mL/min/1.73m2 (using the CKD-EPI equation)
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  • Positive to HBsAg, HCV Ab, HIV and Syphilis regain test (RPR)
  • Systolic blood pressure of > 160 mmHg or < 110 mmHg, or diastolic blood pressure of > 100 mmHg or < 70 mmHg from vital signs measured from sitting position after 3 minutes of resting.
  • Those whose test results at screening other than those mentioned in paragraph 4) above are abnormal and judged clinically significant
  • Those who have participated in other clinical trials and have been administered with other investigational products in 180 days prior to the first administration of the investigational product. (The day after the last administration of any previous clinical trial's investigational product shall be counted as day 1 of the end of trial.)
  • Those who took prescription drugs (including herbal medicine prescriptions) or OTC in 14 days prior to the first administration of the investigational products, or those who have not expressed their consent for drug prohibition from 14 days before the first administration of the investigational products until the end of study. (However, medicinal products may be administered if the subjects' safety and study results are considered to be unaffected according to the investigator's judgement.)
  • Those who have given whole blood donation in 8 weeks before the first administration of the investigational products, who have given plasma/platelet donation or received blood transfusion in 4 weeks before the first administration of the investigational products and who have not expressed their consent for blood-donation prohibition from the first administration of the investigational products until 30 days after the final administration.
  • Those who have history of continuous, excessive smoking or alcohol intake in 6 months before screening (Alcohol: > 21 units/week (1unit=10g=12.5mL); Smoking: > 10 cigarettes/day), those who cannot stop smoking or caffeine intake during hospitalization or those who cannot stop drinking from 48 hours before the first administration throughout the entire study period.
  • ☞ Amount of alcohol (g) = Amount of intake (ml) x alcoholicity (%) x 0.8 (10g=12.5mL)
  • Those who have history of diet (e.g., grapefruit juice) and health/functional food intake that can influence absorption, distribution, metabolism and excretion of the investigational products in 3 days from the first administration of the investigational product or who cannot stop the intake of such diet and food from 3 days before the first administration until the end of study.
  • Those who have drug abuse (especially centrally acting drugs including sleeping pills, centrally acting pain liver, opiates or psychoactive drugs), have history of drug abuse or whose urine drug test is positive.
  • Those who cannot use contraceptive measures (including sterilization operation of the subject and his/her partner, intrauterine contraceptive device and use of diaphragm or condom) that are allowed for clinical trials from the first administration of the investigational products until the last visit.
  • Those who have genetic problems including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
  • Those who have history of hypersensitivity or allergy on Yellow No. 5 (Sunset Yellow FCF) ingredients.
  • Female participants who are pregnant or breastfeeding, or those whose pregnancy test is positive.
  • 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 "BR1017-1" and "BR1017-2" in Healthy Volunteers

To evaluate the influence of BR1017-1 and BR1017-2 on pharmacokinetics and safety when administered separately or co-administered to healthy volunteers.

Read the detailed description

A total of 32 subjects will be enrolled in one sequence group. The investigational products will be administered according to the treatment groups (F, AE, F+AE) assigned to one sequence group in Period 1, Period 2, and Period 3.

Being tested
BR1017-1, BR1017-2
Medical subject headings
Hypertension

What participants receive

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

  • BR1017-1Drug

    Also called Fimasartan 60mg

    Administration to the F/F+AE group: BR1017-1 will be administered 1 tablet QD, five-day repeat dose

  • BR1017-2Drug

    Also called Atorvastatin 40mg / Ezetimibe 10mg

    Administration to the AE group: BR1017-2 will be administered 1 tablet QD, 9-day repeat dose Administration to the F+AE group: BR1017-2 will be administered 1 tablet once QD, 5-day repeat dose.

Study groups in NCT05372380
Study groupRoleWhat they receive
Sequence F/AE/F+AEExperimentalA total of 32 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(F, AE, F+AE) assigned to on sequence group in Period 1, Period 2, and Period 3.
Receives: Drug: BR1017-1; Drug: BR1017-2

What is being measured

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

  1. Pharmacokinetic variables - Maximum (peak) steady-state plasma drug concentration during a dosage interval(Cmax,ss) of Part A and B

    The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Fimasartan alone vs. Fimasartan + Atorvastatin/ Ezetimibe) and Part B (Atorvastatin/Ezetimibe vs. Fimasartan + Atorvastatin/ Ezetimibe).

    Measured: 0~27 days after medication

  2. Pharmacokinetic variables - Area under the plasma concentration-time curve from time zero to time t(AUCt) of Part A and B

    The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Fimasartan alone vs. Fimasartan + Atorvastatin/ Ezetimibe) and Part B (Atorvastatin/Ezetimibe vs. Fimasartan + Atorvastatin/ Ezetimibe).

    Measured: 0~27 days after medication

Secondary outcomes (2)

  1. Pharmacokinetic variables - Time to reach maximum (peak) plasma concentration following drug administration at steady state (Tmax,ss) of Part A and B

    The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Fimasartan alone vs. Fimasartan + Atorvastatin/ Ezetimibe) and Part B (Atorvastatin/Ezetimibe vs. Fimasartan + Atorvastatin/ Ezetimibe).

    Measured: 0~27 days after medication

  2. Pharmacokinetic variables - Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss) of Part A and B

    The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Fimasartan alone vs. Fimasartan + Atorvastatin/ Ezetimibe) and Part B (Atorvastatin/Ezetimibe vs. Fimasartan + Atorvastatin/ Ezetimibe).

    Measured: 0~27 days after medication

Timeline

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

  1. First posted12 May 2022
  2. Study start9 May 2022
  3. Primary completion4 Jun 2022
  4. Study completion30 Jun 2022

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
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05372380
Sponsor's protocol ID
BR-FMS-CT-119
Status last verified
Feb 2023
First submitted
9 May 2022
Last updated
8 Feb 2023
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 BR1017-1 and BR1017-2 in people with Hypertension and Hypercholesterinemia, 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 21 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 8 Feb 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?

Pharmacokinetic variables - Maximum (peak) steady-state plasma drug concentration during a dosage interval(Cmax,ss) of Part A and B (time frame: 0~27 days after medication). 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 NCT05372380.

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 8 Feb 2023.

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Clinical Trial NCT05372380 | AzTrials