Status:
COMPLETED
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Collaborating Sponsors:
Seoul National University Hospital
Conditions:
Renal Impairment
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- \<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
- AST, ALT \> 1.5 times of upper normal range
- positive drug or alcohol screening
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01148368
Start Date
June 1 2010
End Date
July 1 2011
Last Update
January 9 2012
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea