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CompletedNCT01148368Updated Jan 9, 2012

A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers

A Phase 1 interventional study of fimasartan in Renal Impairment, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-09.

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

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in renal impairment patients and healthy volunteers.

02

Conditions studied

  • Renal Impairment

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Keywords

  • fimasartan
  • renal impairment
  • hypertension
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 16 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

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 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

\<Renal impairment patient>

  • age: 20-65 years
  • eGFR: \< 30ml/min/1.73m\^2
  • not on dialysis
  • body weight: greater than 55kg
  • written informed consent

\<Healthy volunteer>

  • age: 20-65 years
  • body weight: greater than 55kg
  • written informed consent

Exclusion criteria

Exclusion Criteria:

  • AST, ALT > 1.5 times of upper normal range
  • positive drug or alcohol screening
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    renal impairment patients

    renal impairment patients who eGFR is lower than 30 ml/min/1.73m\^2 without hemodialysis

    Drug: fimasartan

  • Active comparator
    healthy volunteers

    healthy volunteers group

    Drug: fimasartan

Interventions

  • Drugfimasartan

    single administration of fimasartan 120mg

06

What researchers measure

Primary outcomes

  1. pharmacokinetic characteristic of fimasartan

    AUC, Cmax, Tmax, T1/2, and CL/F of fimasartan

    Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01148368
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Collaborators
Seoul National University Hospital
Responsible party
Sponsor
First posted
Jun 22, 2010
Start date
Jun 2010
Primary completion
Jul 2010
Completion
Jul 2011
Last update
Jan 9, 2012

Study contacts

Yon Su Kim, PhD
principal investigator · Seoul National University College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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