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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Volunteers on dialysis

Group Type EXPERIMENTAL

Tamiflu (oseltamivir)

Intervention Type DRUG

Single dose of Tamiflu in volunteers on dialysis

Volunteers with reduced creatinine clearance

Group Type EXPERIMENTAL

Tamiflu (oseltamivir)

Intervention Type DRUG

Single dose of Tamiflu in volunteers with creatinine clearance from 10 to 30 mL/min

Interventions

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Tamiflu (oseltamivir)

Single dose of Tamiflu in volunteers on dialysis

Intervention Type DRUG

Tamiflu (oseltamivir)

Single dose of Tamiflu in volunteers with creatinine clearance from 10 to 30 mL/min

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes