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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborator: Seoul National University Hospital

Criteria

Inclusion Criteria:

• age: 20-65 years

• eGFR: < 30ml/min/1.73m^2

• not on dialysis

• body weight: greater than 55kg

• written informed consent

• 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