MedDataX Logo

Fimasartan (BR-A-657) Single Oral Dose in Healthy Subjects

NCT ID: NCT01289886

Last Updated: 2011-02-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2003-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic (PK/PD) of ascending single oral dose of BR-A-657 in healthy male subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fimasartan (BR-A-657) Multiple Oral Dose in Healthy Subjects

NCT01289899

Essential Hypertension
COMPLETED PHASE1

Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young Male Volunteers

NCT00937534

Essential Hypertension
COMPLETED PHASE1

Efficacy, Safety and Pharmacodynamic/Pharmacokinetic Study of Fimasartan (BR-A-657•K)

NCT00937651

Essential Hypertension
COMPLETED PHASE2

Antihypertensive Efficacy and Tolerability and Determine the Adequate Antihypertensive Dosage of Fimasartan in Mild to Moderate Essential Hypertension Patients

NCT00923611

Hypertension
COMPLETED PHASE2

Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients

NCT00922480

Hypertension
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

BR-A-657 20, 50, 120, 240, 360, 480mg or placebo were administered once to healthy male subjects.

Pharmacokinetic and Pharmacodynamic(PK/PD) parameters were monitored at pre-specified times from each subjects.

PK parameters: Area Under the Curve(AUC), Cmax, half-life, etc. PD parameters: Aldosterone, Plasma renin activity, Angiotensin I, Angiotensin II Adverse events are reported.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Essential Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

BR-A-657 20mg or placebo

Group Type OTHER

BR-A-657

Intervention Type DRUG

20, 60, 120, 240, 360, 480mg or placebo tablet

Arm B

BR-A-657 60mg or placebo

Group Type OTHER

BR-A-657

Intervention Type DRUG

20, 60, 120, 240, 360, 480mg or placebo tablet

Arm C

BR-A-657 120mg or placebo

Group Type OTHER

BR-A-657

Intervention Type DRUG

20, 60, 120, 240, 360, 480mg or placebo tablet

Arm D

BR-A-657 240mg or placebo

Group Type OTHER

BR-A-657

Intervention Type DRUG

20, 60, 120, 240, 360, 480mg or placebo tablet

Arm E

BR-A-657 480mg or placebo

Group Type OTHER

BR-A-657

Intervention Type DRUG

20, 60, 120, 240, 360, 480mg or placebo tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BR-A-657

20, 60, 120, 240, 360, 480mg or placebo tablet

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fimasartan 20, 60, 120, 240, 360, 480mg

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* male of 18-55 years old
* Body Mass Index(BMI) 19-29kg/m2
* subjects in good health
* subjects with written informed consent

Exclusion Criteria

* subjects with multiple drug allergy or allergy to Angiotensin Receptor Blocker(ARB)
* subjects with medication that affect drug absorption or elimination within 30days.
* subjects with orthostatic hypotension of \>20mmHg decrease of Systolic Blood Pressure(SBP)
* subjects with history of neurologic, liver, renal, gastrointestinal, cardiovascular, psychological or other major disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Covance

INDUSTRY

Sponsor Role collaborator

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Boryung Pharm. Co., Ltd

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

E Engmann, MB ChB

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research Unit

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2290/2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension
NCT00922441 COMPLETED PHASE2
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers
NCT01146938 COMPLETED PHASE1
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers
NCT01148368 COMPLETED PHASE1
A Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate Essential Hypertension
NCT01672476 COMPLETED PHASE3
A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of Fimasartan
NCT02620306 COMPLETED PHASE3
The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension
NCT01135212 COMPLETED PHASE3
Effect of High- and Low-sodium Intake on the Pharmacokinetics and Pharmacodynamic Effects of Fimasartan
NCT02147704 COMPLETED PHASE4
A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy
NCT05878561 COMPLETED PHASE3
Fimasartan Achieving SBP Target (FAST) Study
NCT02495324 COMPLETED PHASE4
A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy
NCT01258673 COMPLETED PHASE3
A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers
NCT03250052 COMPLETED PHASE1
Efficacy of fimaSartan on arTerIal stiFFness iN patiEntS With HypertenSion
NCT02022774 COMPLETED
A Valsartan 80 Mg-Referenced, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension
NCT01878201 COMPLETED PHASE2
A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers
NCT00938132 COMPLETED PHASE1
Olmesartan Medoxomil Versus Losartan in Patients With Hypertension
NCT00857285 COMPLETED PHASE3
Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial Hypertension
NCT02248961 COMPLETED PHASE3
Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension
NCT01615198 COMPLETED PHASE3
A Trial of Fimasartan for Early Diastolic Heart Failure
NCT01691118 COMPLETED PHASE4
Clinical Characteristics and Medication Satisfaction of Kanarb Tablet in Korean Hypertensive Patient(Kanarb-Hypertension Epidemiology Medication Satisfaction Study)
NCT02394392 COMPLETED
Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential Hypertension
NCT00856271 COMPLETED PHASE3
Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject
NCT02504606 COMPLETED PHASE1
A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/Hydrochlorothiazide
NCT02222480 COMPLETED PHASE2
A Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment
NCT02448628 COMPLETED PHASE2
Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan
NCT04991207 COMPLETED PHASE1
New Angiotensin II Receptor Blocker Azilsartan Study for Stronger Blood Pressure Lowering
NCT01609959 COMPLETED PHASE4