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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01289886
First Posted: February 4, 2011
Last Update Posted: February 4, 2011
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.
Collaborator:
Covance
Information provided by:
Boryung Pharmaceutical Co., Ltd
  Purpose
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.

Condition Intervention Phase
Essential Hypertension Drug: BR-A-657 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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

Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 40
Study Start Date: September 2003
Study Completion Date: December 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01289886


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

Responsible Party: Paik, Assistant manager, Boryung Pharm. Co., Ltd
ClinicalTrials.gov Identifier: NCT01289886     History of Changes
Other Study ID Numbers: 2290/2
First Submitted: December 13, 2010
First Posted: February 4, 2011
Last Update Posted: February 4, 2011
Last Verified: January 2011

Keywords provided by Boryung Pharmaceutical Co., Ltd:
single-dose
pharmacokinetic
pharmacodynamic
safety