NCT01671020

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

1 month

First QC Date

August 20, 2012

Last Update Submit

June 29, 2016

Conditions

Healthy

Keywords

fimasartanabsolute bioavailability

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

(R)(T)

ACTIVE COMPARATOR

Period 1: Fimasartan 60mg → Period 2: Fimasartan 30mg

Drug: Fimasartan

(T)(R)

ACTIVE COMPARATOR

Period 1: Fimasartan 30mg → Period 2: Fimasartan 60mg

Drug: Fimasartan

Interventions

FimasartanDRUG

Period 1 fisrt administration of fimasartan 60mg Period 2 second administration of fimasartan 30mg

(R)(T)

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Busan Paik Hospital

Busan, South Korea

Location

MeSH Terms

Interventions

fimasartan

Study Officials

  • Jae-Gook Shin, M.D, Ph.d

    Division of Clinical Pharmacology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2012

First Posted

August 23, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 1, 2016

Record last verified: 2016-06

Locations

KR(1)