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CompletedNCT06636877Updated Dec 13, 2024

A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-3" and "BR1019-2" in Healthy Volunteers

A Phase 1 interventional study of BR1019 and BR1019-2 in Essential Hypertension and Type 2 Diabetes, 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 2024-12-13.

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

Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-3" and "BR1019-2" in healthy volunteers

02

Conditions studied

  • Essential Hypertension
  • Type 2 Diabetes
03

In context

Essential Hypertension

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

This study's enrollment of 52 is below the median of 166 across 458 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 143 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Those have body mass index (BMI) within the range of 18.0 to 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 spontaneously decide to participate and sign written consent to comply with the subject's precautions during the clinical trial period after listening to and fully understanding detailed explanation of this clinical trial
  • 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 the first administration of the investigational products to 7 days after the last administration and disagrees 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 prior to the first day of administration or have taken ETC, OTC, Oriental medicine, health functional food concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetic and pharmacodynamic properties such as Interaction of investigational products, half-life)
  • Those who have participated in bioequivalence tests or other clinical trials and administered their investigational products within 6 months prior to 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 have a medical history of gastrointestinal surgery (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
  • In the case of a female subject, pregnant woman, those suspected pregnancy or lactating woman.
05

Study design

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

Study arms

  • Experimental
    BR1019

    Drug: BR1019

  • Active comparator
    BR1019-2 + BR1019-3

    Drug: BR1019-2 · Drug: BR1019-3

Interventions

  • DrugBR1019

    One tablet administered alone

  • DrugBR1019-2

    One tablet administered alone

  • DrugBR1019-3

    One tablet administered alone

06

What researchers measure

Primary outcomes

  1. Area under the concentration-time curve from time zero to time τ

    Time frame: 0-48 hours after administration

  2. Maximum concentration of drug in plasma

    Time frame: 0-48 hours after administration

07

Study locations

1 site
  • Clinical Research Center, H PLUS Yangji Hospital
    Seoul, Gwanakgu 08779, 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 Dec 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06636877
Responsible party
Sponsor
First posted
Oct 15, 2024
Start date
Oct 23, 2024
Primary completion
Dec 11, 2024
Completion
Dec 11, 2024
Last update
Dec 13, 2024

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 Dec 2024. You cannot join it, but the record below documents what was studied.

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