NCT02780622

A Pharmacokinetics, Pharmacodynamics and Safety Study of Warfarin in Combination With Tamiflu (Oseltamivir)

An Open-label, Randomized 2-period Crossover Study to Investigate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Warfarin in Combination With Oseltamivir in Volunteers Stabilized on Warfarin Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized, 2-period crossover study, to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of warfarin in combination with Tamiflu (oseltamivir) in participants stabilized on warfarin. Participants will be randomized to receive either their warfarin followed oseltamivir and warfarin, or by oseltamivir and warfarin followed by warfarin. The treatment periods will be separated by a washout period of at least 4 days. Participants will continue receiving warfarin once daily at a prescribed usual dose throughout the study.

Conditions

• Drug Therapy, Combination

Interventions

Type	Name	Description
DRUG	Oseltamivir	Oseltamivir 75 mg orally, twice daily for 4 days and once on Day 5.
DRUG	Warfarin	Warfarin once daily, at a dose determined through titration by participants' usual hematologist.

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2016-05-23
• Last updated: 2016-10-26
• Results posted: 2016-09-12

Locations

1 site across 1 country: United Kingdom