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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

This study has been completed.
Sponsor:
Collaborator:
Seoul National University Hospital
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01148368
First received: June 21, 2010
Last updated: January 6, 2012
Last verified: December 2010
History of Changes
  Purpose

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 Intervention Phase
Renal Impairment
 Drug: fimasartan
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boryung Pharmaceutical Co., Ltd:

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


Enrollment: 16
Study Start Date: June 2010
Study Completion Date: July 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01148368     History of Changes
Other Study ID Numbers: A657-BR-CT-113
Study First Received: June 21, 2010
Last Updated: January 6, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013