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

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ClinicalTrials.gov Identifier: NCT01148368
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : January 9, 2012
Sponsor:
Collaborator:
Seoul National University Hospital
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: fimasartan Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers
Study Start Date : June 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: renal impairment patients
renal impairment patients who eGFR is lower than 30 ml/min/1.73m^2 without hemodialysis
Drug: fimasartan
single administration of fimasartan 120mg

Active Comparator: healthy volunteers
healthy volunteers group
Drug: fimasartan
single administration of fimasartan 120mg




Primary Outcome Measures :
  1. pharmacokinetic characteristic of fimasartan [ Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h ]
    AUC, Cmax, Tmax, T1/2, and CL/F of fimasartan



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148368


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Seoul National University Hospital
Investigators
Principal Investigator: Yon Su Kim, PhD Seoul National University College of Medicine

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01148368     History of Changes
Other Study ID Numbers: A657-BR-CT-113
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: January 9, 2012
Last Verified: December 2010

Keywords provided by Boryung Pharmaceutical Co., Ltd:
fimasartan
renal impairment
hypertension

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases