A Single Dose Study of Tamiflu in Volunteers in Dialysis And in Volunteers With Reduced Creatinine Clearance

An Open Label, Prospective, Single Oral Dose Study Evaluating the Pharmacokinetics, Safety, and Tolerability of Oseltamivir in Adult Subjects on Peritoneal Dialysis (PD) Using a Rapid Cycle Regimen to Simulate APD and in Adult Subjects With Creatinine Clearance From 10 to 30 mL/Min Not on Dialysis

This open-label, prospective, single dose study will evaluate the pharmacokinetics and safety of Tamiflu (oseltamivir) in volunteers on dialysis and in volunteers with a creatinine clearance from 10 to 30 mL/min. Volunteers will receive a single oral dose of Tamiflu.

Inclusion Criteria:

General

• Adult volunteers, aged 19 to 90 years
• Medically stable with no hospitalization for a significant disease in the 3 months before study start

Volunteers on dialysis

• A documented and well-established dialysis therapy

Volunteers with reduced creatinine clearance

• Creatinine clearance from 10 to 30 mL/min
• Stable renal function

Exclusion Criteria:

• Clinically significant and unstable disease (e.g., cardiac, hepatic, pulmonary)
• Medical history of concurrent medical condition that would compromise participation in the study
• Hypotensive episodes or symptoms of fainting, dizziness or lightheadedness in the 4 weeks before screening
• Uncontrolled hypotension or hypertension
• Infection with hepatitis B, hepatitis C or human immunodeficiency virus