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
  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:


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
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, see Learn About Clinical Studies.

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 October 01, 2014