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COMPLETEDPHASE1

A Study to Evaluate Drug-drug Interactions Between BR1017-1 and BR1017-2 in Healthy Volunteers

An Open Label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions and Safety Between "BR1017-1" and "BR1017-2" in Healthy Volunteers

NCT05372380•Boryung Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

To evaluate the influence of BR1017-1 and BR1017-2 on pharmacokinetics and safety when administered separately or co-administered to healthy volunteers.

Detailed Description

A total of 32 subjects will be enrolled in one sequence group. The investigational products will be administered according to the treatment groups (F, AE, F+AE) assigned to one sequence group in Period 1, Period 2, and Period 3.

Eligibility

Age

19 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Health adults aged 19 to 55 at screening.
•2. Male adults whose weight is ≥50kg and female adults whose weight is ≥45kg, and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2 BMI (kg/m2) = weight (kg) / \[height (m)\]2
•3. Those who are given detailed explanations about the trial and express their voluntary consent to participate in the trial by signing a written consent before screening procedure begins.

Exclusion Criteria

•1. Those who have history of clinically significant diseases including hypersensitivity reaction, intolerability and anaphylaxis to major ingredients and other ingredients of the investigational products.
•2. Those who have history of clinically significant diseases related to liver (including severe hepatopathy), kidney (including severe renal impairment), digestive system (including pancreatitis), respiratory system, musculoskeletal system, endocrine system (patients with diabetic ketoacidosis, diabetic coma and precoma, type 1 diabetes, etc.), neuropsychiatric system, hemato-oncology system, cardiovascular system (including heart failure and orthostatic hypotension), etc.
•3. Those who have medical history of gastrointestinal system diseases (for example: Crohn's disease, peptic ulcer disease, etc.) or operations that may influence the absorption of investigational products. (However, appendectomy, hernia operation, endoscopic polypectomy and hemorrhoids/anal fissure/anal fistula surgeries are excluded.)
•4. Those who are judged unfit for the trial at screening as follows:
•* Serum ALT, AST and total bilirubin \> twice the upper limit of normal levels
•* e-GFR \< 60 mL/min/1.73m2 (using the CKD-EPI equation)
•* Positive to HBsAg, HCV Ab, HIV and Syphilis regain test (RPR)
•* Systolic blood pressure of \> 160 mmHg or \< 110 mmHg, or diastolic blood pressure of \> 100 mmHg or \< 70 mmHg from vital signs measured from sitting position after 3 minutes of resting.
•5. Those whose test results at screening other than those mentioned in paragraph 4) above are abnormal and judged clinically significant
•6. Those who have participated in other clinical trials and have been administered with other investigational products in 180 days prior to the first administration of the investigational product. (The day after the last administration of any previous clinical trial's investigational product shall be counted as day 1 of the end of trial.)
+11 more criteria

Locations (1)

CHA Bundang Medical Center, CHA University

Gyeonggi-do, Seongnam-si, South Korea

Key Dates

Start Date

May 9, 2022

Primary Completion Date

June 4, 2022

Completion Date

June 30, 2022

Last Updated

February 8, 2023

Enrollment

ACTUAL participants

Conditions

HypertensionHypercholesterinemia

Interventions

BR1017-1

DRUG

BR1017-2

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate Drug-drug Interactions Between BR1017-1 and BR1017-2 in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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