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

June 21, 2010
January 6, 2012
June 2010
July 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01148368 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Renal Impairment
Drug: fimasartan
single administration of fimasartan 120mg
  • Experimental: renal impairment patients
    renal impairment patients who eGFR is lower than 30 ml/min/1.73m^2 without hemodialysis
    Intervention: Drug: fimasartan
  • Active Comparator: healthy volunteers
    healthy volunteers group
    Intervention: Drug: fimasartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2011
July 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01148368
A657-BR-CT-113
Yes
Boryung Pharmaceutical Co., Ltd
Boryung Pharmaceutical Co., Ltd
Seoul National University Hospital
Principal Investigator: Yon Su Kim, PhD Seoul National University College of Medicine
Boryung Pharmaceutical Co., Ltd
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP