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

This study has been completed.
Sponsor:
Collaborator:
Covance Clinical Research Unit Ltd.
Information provided by:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01289886
First received: December 13, 2010
Last updated: February 3, 2011
Last verified: January 2011
History of Changes
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289886

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

No publications provided

Responsible Party: Paik, Assistant manager, Boryung Pharm. Co., Ltd
ClinicalTrials.gov Identifier: NCT01289886     History of Changes
Other Study ID Numbers: 2290/2
Study First Received: December 13, 2010
Last Updated: February 3, 2011
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013