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

Phase 1 Completed 16 enrolled Hoffmann-La Roche

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2012-03
Primary completion: 2012-06
Completion: 2012-06

Publications

Patel K, Rayner CR, Giraudon M, Kamal MA, Morcos PN, Robson R, Kirkpatrick CM. Pharmacokinetics and safety of oseltamivir in patients with end-stage renal disease treated with automated peritoneal dialysis. Br J Clin Pharmacol. 2015 Apr;79(4):624-35. doi: 10.1111/bcp.12526.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oseltamivir	Small molecule	75 mg	Oral

Indications

No indication recorded.