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CompletedNCT01007409Updated Dec 24, 2009

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

A Phase 1 interventional study of Fimasartan and Fimasartan in Healthy, sponsored by Boryung Pharmaceutical Co., Ltd. Completed. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-24.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers
03

In context

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • age: 20 - 45 years
  • sex: male
  • body weight: greater than 55 kg
  • written informed consent

Exclusion criteria

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Group B

    Period 1: fed control → Period 2: fasted control

    Drug: Fimasartan

  • Active comparator
    Group A

    Period 1: fasted control → Period 2: fed control

    Drug: Fimasartan

Interventions

  • DrugFimasartan

    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

  • DrugFimasartan

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01007409
Lead sponsor
Boryung Pharmaceutical Co., Ltd
First posted
Nov 4, 2009
Start date
Oct 2009
Primary completion
Nov 2009
Last update
Dec 24, 2009
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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