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A Clinical Trial to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers

NCT ID: NCT05097794

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-16

Study Completion Date

2021-10-22

Brief Summary

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The purpose of this study is to evaluate pharmacokinetic interactions (Drug-Drug interaction) and safety between "BR1015-1" and "BR1015-2" in healthy volunteers.

Detailed Description

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\*Study Objective: After repeated administration of BR1015-1 and BR1015-2 for healthy volunteers, the pharmacokinetic interactions and safety are evaluated.

\*Investigational Product (and regimen)

1. BR1015-1: Administration of BR1015-1 60 mg once a day for 5 days
2. BR1015-2: Administration of BR1015-2 1.5 mg once a day for 5 days
3. BR1015-1+BR1015-2: Co-administration of BR1015-1 60 mg and BR1015-2 1.5 mg once a day for 5 days

Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

One-sequence, 3-period study.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

BR1015-1

Intervention Type DRUG

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

BR1015-2

Intervention Type DRUG

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

BR1015-1 + BR1015-2

Intervention Type DRUG

\- 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.

Interventions

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BR1015-1

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

Intervention Type DRUG

BR1015-2

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

Intervention Type DRUG

BR1015-1 + BR1015-2

\- 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.

Intervention Type DRUG

Other Intervention Names

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Fimasartan 60 mg Indapamide 1.5 mg Fimasartan and Indapamide

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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An-Hye Kim, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

CHA University

Locations

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CHA Bundang Medical Center, CHA University

Gyeonggi-do, Seongnam-si, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BR-FMS-CT-118

Identifier Type: -

Identifier Source: org_study_id