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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Oseltamivir

Criteria

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