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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01289899
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : February 4, 2011
Information provided by:
Boryung Pharmaceutical Co., Ltd

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

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: BR-A-657 Phase 1

Detailed Description:

BR-A-657 120, 360, or placebo were administered once daily for 7days to 16 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 : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Multiple Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects
Study Start Date : January 2004
Primary Completion Date : February 2004
Study Completion Date : February 2004

Arm Intervention/treatment
Experimental: Arm A
BR-A-657 120mg or placebo
Drug: BR-A-657
120, 360mg or placebo 7days
Other Name: Fimasartan
Experimental: Arm B
BR-A-657 360mg or placebo
Drug: BR-A-657
120, 360mg or placebo 7days
Other Name: Fimasartan

Primary Outcome Measures :
  1. No of subjects with Adverse events(AE) from each observations [ Time Frame: up to 5~7days post final(7th) dose ]
    1. AE reporting: Day 1: Predose, 3 & 12h, Days 2~7: Predose, Days 8,9: Once daily, 5~7days post final dose
    2. Vital signs: Day 1: Predose, 0.5,1,2,4,8,12,24h,Days 3~6: Predose Day 7: Predose, 0.5,1,2,4,8,12,24,48h, 5~7days post final dose
    3. ECG: Days 1 & 7: Predose, 2, 4, 8 & 24h, Day 4: Predose, 5~7days post final dose
    4. Laboratory examination: Days 1 & 4: Predose, Day 7: Predose & 24h, 5~7days post final dose
    5. Physical examination: predose, 5~7days post final dose
    6. Body weight: predose, Days 4 & 8

Secondary Outcome Measures :
  1. Area under the plasma concentration time curve (AUC) [ Time Frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 ]
  2. Maximum observed plasma concentration (Cmax). [ Time Frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 ]
  3. parent plasma terminal elimination half life (t½) [ Time Frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 ]
  4. Apparent total plasma clearance (CL/F) [ Time Frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 ]
  5. Accumulation ratio (RA) [ Time Frame: predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7 ]

    RA1=Accumulation ratio based on AUCinf

    RA2=Accumulation ratio based on Cmax

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • male of 18-55 years old
  • BMI 19-29kg/m2
  • subjects in good health
  • subjects with written informed consent

Exclusion Criteria:

  • subjects with multiple drug allergy or allergy to ARB
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01289899

Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Principal Investigator: E Engmann, MB ChB Covance Clinical Research Unit

Responsible Party: Paik, Assistant manager, Boryung Pharm. Co., Ltd Identifier: NCT01289899     History of Changes
Other Study ID Numbers: 2290/9
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: February 4, 2011
Last Verified: February 2011

Keywords provided by Boryung Pharmaceutical Co., Ltd: