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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01671020
First received: August 20, 2012
Last updated: June 29, 2016
Last verified: June 2016
  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 ]

Enrollment: 16
Study Start Date: June 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (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   (Adult)
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
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: 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
  More Information

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: June 29, 2016
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 August 23, 2016