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

This study is currently recruiting participants.
Verified August 2012 by Boryung Pharmaceutical Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01671020
First received: August 20, 2012
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Healthy
Drug: Fimasartan
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: June 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671020

Locations
Korea, Republic of
Inje University Busan Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: Jae Gook Shin, Ph.D    82-51-890-0603    phshinjg@gmail.com   
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
  More Information

No publications provided

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01671020     History of Changes
Other Study ID Numbers: A657-BR-CT-115
Study First Received: August 20, 2012
Last Updated: August 22, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on April 17, 2014