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

Sponsor

Boryung Pharmaceutical Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT01671020

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

16.2

Patients Per Site Per Month

Study Details

Study Description

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 Drug: Fimasartan	Phase 1

Study Design

Study Type:

Interventional

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 :

Jun 1, 2012

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

AUCinf, AUC, Cmax, Tmax, half-life; t1/2z, AUCt, Vdss, Cl, [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boryung Pharmaceutical Co., Ltd

ClinicalTrials.gov Identifier:

NCT01671020

Other Study ID Numbers:

A657-BR-CT-115

First Posted:

Aug 23, 2012

Last Update Posted:

Jul 1, 2016

Last Verified:

Jun 1, 2016

Keywords provided by Boryung Pharmaceutical Co., Ltd

fimasartan

absolute bioavailability

Study Results

No Results Posted as of Jul 1, 2016