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Clinical Trials/NCT01148368
NCT01148368
Completed
Phase 1

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

Boryung Pharmaceutical Co., Ltd1 site in 1 country16 target enrollmentJune 2010
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ConditionsRenal Impairment
Interventionsfimasartan
Drugsfimasartan

Overview

Phase
Phase 1
Intervention
fimasartan
Conditions
Renal Impairment
Sponsor
Boryung Pharmaceutical Co., Ltd
Enrollment
16
Locations
1
Primary Endpoint
pharmacokinetic characteristic of fimasartan
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
July 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

renal impairment patients

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

Intervention: fimasartan

healthy volunteers

healthy volunteers group

Intervention: fimasartan

Outcomes

Primary Outcomes

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

Study Sites (1)

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