CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Tamiflu (oseltamivir) +1 moredrug
Likely dose
Tamiflu (oseltamivir) 30 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01556633
NCT01556633Phase 1Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted Mar 16, 2012·Updated Jul 7, 2016

In Brief

A Phase 1 clinical trial evaluating Tamiflu (oseltamivir) for Healthy Volunteer. Completed, enrolled 16 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer
CountriesNew Zealand
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2012
Enrollment StartMar 1, 2012
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.3 years ago

Interventions

Tamiflu (oseltamivir)drug

Single dose of Tamiflu in volunteers on dialysis

Tamiflu (oseltamivir)drug

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