Essential HypertensionPhase 1NCT06889012
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1018 and Coadministration of BR1018A and BR1018B in Healthy Adult Volunteers
A Phase 1 study testing BR1018, BR1018A and BR1018B in people with Essential Hypertension and Primary Hypercholesterolemia, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this clinical study is to evaluate the pharmacokinetics and the safety after administration of BR1018 and coadministration of BR1018A and BR1018B in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension, Primary Hypercholesterolemia
- What is being tested?
- BR1018, BR1018A and BR1018B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 May 2025to 23 Jul 2025
- Phase
- Phase 1
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who have body mass index (BMI) of more than 18.0kg/m2 and less than 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 sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
- 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 consent to 14 days after the last administration and disagree 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.
Who cannot join
- Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days before the first administration date or have taken drugs concerned about affecting this clinical trial within 10 days before the first administration date. (However, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
- Those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
- Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before 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 can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours before the first administration date
- In the case of a female subject, those suspected pregnancy or pregnant woman or lactating woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 4-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1018" and Coadministration of "BR1018A" and "BR1018B" in Healthy Volunteers
The purpose of this clinical study is to evaluate the pharmacokinetics and the safety after administration of BR1018 and coadministration of BR1018A and BR1018B in healthy volunteers
- Being tested
- BR1018, BR1018A, BR1018B
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR1018Drug
One tablet administered alone
BR1018ADrug
One tablet administered alone
BR1018BDrug
One tablet administered alone
| Study group | Role | What they receive |
|---|---|---|
| BR1018 | Experimental | Not described Receives: Drug: BR1018 |
| BR1018A+BR1018B | Active comparator | Not described Receives: Drug: BR1018A; Drug: BR1018B |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Area under the plasma drug concentration-time curve from 0 to time t
Measured: 0-72 hours after administration
Cmax
Maximum concentration of drug in plasma
Measured: 0-72 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start7 May 2025
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889012
- Sponsor's protocol ID
- BR-FAEAC-CT-103
- Status last verified
- Sep 2025
- First submitted
- 17 Mar 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No