NCT05097794

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
Last Updated

November 22, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

October 17, 2021

Last Update Submit

November 18, 2021

Conditions

Hypertension

Outcome Measures

Primary Outcomes (4)

  • [Part A] Cmax,ss of BR1015-1

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

    0~24 hour after administration at Day 5.

  • [Part B] Cmax,ss of BR1015-2

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

    0~24 hour after administration at Day 5.

  • [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)

    0~24 hour after administration at Day 5.

  • [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)

    0~24 hour after administration at Day 5.

Secondary Outcomes (8)

  • [Part A] AUClast of BR1015-1

    0~48 hour after administration

  • [Part B] AUClast of BR1015-2

    0~48 hour after administration

  • [Part A] AUCinf of BR1015-1

    0~48 hour after administration

  • [Part B] AUCinf of BR1015-2

    0~48 hour after administration

  • [Part A] Tmax of BR1015-1

    0~24 hour after administration

  • +3 more secondary outcomes

Study Arms (1)

Sequence BR1015-1/BR1015-2/BR1015-1 + BR1015-2

EXPERIMENTAL

A 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

Drug: BR1015-1Drug: BR1015-2Drug: BR1015-1 + BR1015-2

Interventions

BR1015-1DRUG

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

Also known as: Fimasartan 60 mg
Sequence BR1015-1/BR1015-2/BR1015-1 + BR1015-2
BR1015-2DRUG

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

Also known as: Indapamide 1.5 mg
Sequence BR1015-1/BR1015-2/BR1015-1 + BR1015-2
BR1015-1 + BR1015-2DRUG

\- 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.

Also known as: Fimasartan and Indapamide
Sequence BR1015-1/BR1015-2/BR1015-1 + BR1015-2

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center, CHA University

Gyeonggi-do, Seongnam-si, 13520, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

fimasartanIndapamide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • An-Hye Kim, M.D. Ph.D

    CHA University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: One-sequence, 3-period study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2021

First Posted

October 28, 2021

Study Start

August 16, 2021

Primary Completion

October 22, 2021

Study Completion

October 22, 2021

Last Updated

November 22, 2021

Record last verified: 2021-10

Locations

KR(1)