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NCT Number: NCT01671020

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

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

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inje University Busan Paik Hospital

Busan, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fimasartan

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 23, 2012
Registry last updated
Jul 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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