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