Fimasartan (BR-A-657) Multiple Oral Dose in Healthy Subjects
NCT ID: NCT01289899
Last Updated: 2011-02-04
Study Results
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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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2004-01-31
2004-02-29
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Arm A
BR-A-657 120mg or placebo
BR-A-657
120, 360mg or placebo 7days
Arm B
BR-A-657 360mg or placebo
BR-A-657
120, 360mg or placebo 7days
Interventions
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BR-A-657
120, 360mg or placebo 7days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI 19-29kg/m2
* subjects in good health
* subjects with written informed consent
Exclusion Criteria
* subjects with medication that affect drug absorption or elimination within 30days.
* subjects with orthostatic hypotension of \>20mmHg decrease of sbp
* subjects with history of neurologic, liver, renal, GI, CV, psychological or other major disorder
18 Years
55 Years
MALE
Yes
Sponsors
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Covance
INDUSTRY
Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Boryung Pharm. Co., Ltd
Principal Investigators
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E Engmann, MB ChB
Role: PRINCIPAL_INVESTIGATOR
Covance Clinical Research Unit
Other Identifiers
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2290/9
Identifier Type: -
Identifier Source: org_study_id
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