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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: fimasartan

• Registration Number: NCT01148368
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Primary Completion: 2010-07
• Status Verified: 2010-12
• Study Completion: 2011-07
• Last Update Submitted: 2012-01-06
• Last Update Posted: 2012-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
renal impairment patients	fimasartan	renal impairment patients who eGFR is lower than 30 ml/min/1.73m\^2 without hemodialysis
healthy volunteers	fimasartan	healthy volunteers group

Primary Outcome Measures

Name	Time	Method
pharmacokinetic characteristic of fimasartan	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of