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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteer

Intervention: Tamiflu (oseltamivir) (Drug); Tamiflu (oseltamivir) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche


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.

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pharmacokinetics (Area under the concentration time curve)

Secondary outcome: Safety (Incidence of adverse events)


Minimum age: 19 Years. Maximum age: 90 Years. Gender(s): Both.


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 epsiodes 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

Locations and Contacts

Christchurch 8011, New Zealand

Grafton 1010, New Zealand

Additional Information

Starting date: March 2012
Last updated: August 17, 2015

Page last updated: August 23, 2015

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