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Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01671020
Recruitment Status : Completed
First Posted : August 23, 2012
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

Brief Summary:
Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb® tablet (fimasartan) in healthy subjects

Condition or disease Intervention/treatment Phase
Healthy Drug: Fimasartan Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Open-label, Randomized, Crossover Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects
Study Start Date : June 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Active Comparator: (R)(T)
Period 1: Fimasartan 60mg → Period 2: Fimasartan 30mg
Drug: Fimasartan
Period 1 fisrt administration of fimasartan 60mg Period 2 second administration of fimasartan 30mg
Active Comparator: (T)(R)
Period 1: Fimasartan 30mg → Period 2: Fimasartan 60mg
Drug: Fimasartan
Period 1 first administration of fimasartan 30mg Period 2 second administration of fimasartan 60mg



Primary Outcome Measures :
  1. AUCinf, AUC, Cmax, Tmax, half-life; t1/2z, AUCt, Vdss, Cl, [ Time Frame: PO : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr, IV : 0.25, 0.5, 0.75, 1, 1.08, 1.17, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age: 20 - 55 years
  • body weight: standard weight(Broca's index, Possible range is plus or minus 20percent)
  • written informed consent

Exclusion Criteria:

  • known allergy to Fimasartan
  • existing cardiac or hematological diseases
  • existing hepatic and renal diseases
  • existing gastrointestinal diseases
  • acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder
  • abnormal diet which could affect drug absorption or metabolism
  • positive drug or alcohol screening
  • smokers of 10 or more cigarettes per day
  • participation in a clinical trial during the last 90 days prior to the start of the study

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): NCT01671020


Locations
Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
Principal Investigator: Jae-Gook Shin, M.D, Ph.d Division of Clinical Pharmacology

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01671020     History of Changes
Other Study ID Numbers: A657-BR-CT-115
First Posted: August 23, 2012    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016

Keywords provided by Boryung Pharmaceutical Co., Ltd:
fimasartan
absolute bioavailability