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CompletedNCT06889012Updated Sep 12, 2025

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 interventional study of BR1018 and BR1018A in Essential Hypertension and Primary Hypercholesterolemia, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Essential Hypertension
  • Primary Hypercholesterolemia
03

In context

Essential Hypertension

527 studies on the registry are indexed under Essential Hypertension; 76 are open to participants now.

This study's enrollment of 60 is below the median of 166 across 449 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    BR1018

    Drug: BR1018

  • Active comparator
    BR1018A+BR1018B

    Drug: BR1018A · Drug: BR1018B

Interventions

  • DrugBR1018

    One tablet administered alone

  • DrugBR1018A

    One tablet administered alone

  • DrugBR1018B

    One tablet administered alone

06

What researchers measure

Primary outcomes

  1. AUCt

    Area under the plasma drug concentration-time curve from 0 to time t

    Time frame: 0-72 hours after administration

  2. Cmax

    Maximum concentration of drug in plasma

    Time frame: 0-72 hours after administration

07

Study locations

1 site
  • Clinical Research Center, H PLUS Yangji Hospital
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06889012
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Mar 21, 2025
Start date
May 7, 2025
Primary completion
Jul 23, 2025
Completion
Jul 23, 2025
Last update
Sep 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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