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OpenTrials
Completed

NCT Number: NCT01007409

A Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age: 20 - 45 years
  • sex: male
  • body weight: greater than 55 kg
  • 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 60 days prior to the start of the study

Treatment and study plan

Fimasartan

Drug

Period 1: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast Period 2: administration of fimasartan 240mg at 9:00am, without the breakfast

Primary outcomes

  1. Cmax, Tmax, AUC, T1/2, CL/F etc.

    Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

Randomized, Open-labeled, Single Dosing Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Important dates

Study start
2009
Primary completion
2009
First posted
Nov 4, 2009
Registry last updated
Dec 24, 2009

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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