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

February 3, 2011 updated by: Boryung Pharmaceutical Co., Ltd

BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Single Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects Incorporating a Comparison of Fed/Fasted Pharmacokinetics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Arm A
BR-A-657 20mg or placebo
Drug: BR-A-657
20, 60, 120, 240, 360, 480mg or placebo tablet
Other Names:
  • Fimasartan
  • 20, 60, 120, 240, 360, 480mg
Other: Arm B
BR-A-657 60mg or placebo
Drug: BR-A-657
20, 60, 120, 240, 360, 480mg or placebo tablet
Other Names:
  • Fimasartan
  • 20, 60, 120, 240, 360, 480mg
Other: Arm C
BR-A-657 120mg or placebo
Drug: BR-A-657
20, 60, 120, 240, 360, 480mg or placebo tablet
Other Names:
  • Fimasartan
  • 20, 60, 120, 240, 360, 480mg
Other: Arm D
BR-A-657 240mg or placebo
Drug: BR-A-657
20, 60, 120, 240, 360, 480mg or placebo tablet
Other Names:
  • Fimasartan
  • 20, 60, 120, 240, 360, 480mg
Other: Arm E
BR-A-657 480mg or placebo
Drug: BR-A-657
20, 60, 120, 240, 360, 480mg or placebo tablet
Other Names:
  • Fimasartan
  • 20, 60, 120, 240, 360, 480mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
No of subjects with Adverse events(AE) from each observations
Time Frame: up to 5~7days post-dose
  1. AE reporting: Pre dose, 3, 12, 24h, (48 h: Groups C, D, E) post dose
  2. Vital signs: Pre dose*, 0.5, 1*, 2, 4*, 6, 8*, 12 and 24* h post dose (*:both supine and standing)
  3. ECG: Pre dose, 2, 4, 8 and 24 h post dose
  4. Clinical laboratory examination: Pre dose and 24 h post dose
  5. Physical examination: predose, 5~7days post dose
  6. Body weight: predose, 5~7days post dose
up to 5~7days post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Area under the plasma concentration time curve (AUC)
Time Frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
Maximum observed plasma concentration (Cmax)
Time Frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
Time of the maximum observed plasma concentration (Tmax)
Time Frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
Apparent total plasma clearance (CL/F)
Time Frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
Apparent plasma terminal elimination half life (t½)
Time Frame: 0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h
0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boryung Pharmaceutical Co., Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Covance

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: E Engmann, MB ChB, Covance Clinical Research Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2290/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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