At a glance
ClinicalIndex Comparison Record- ✓Receiving warfarin once daily for at least 4 weeks prior to Screening
- ✓INR within target range of 2.0–3.5
- ✓Regular INR monitoring during warfarin therapy and willing to be trained on CoaguCheck devices
- ✓BMI 18–32 kg/m² inclusive
- ✕INR <2.0 or >3.5 between Screening and Day -1
- ✕Any change in prescribed daily warfarin dose between Screening and Day -1
- ✕History of coagulopathy
- ✕Consumption of health products or supplements containing vitamin K
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Oseltamivir and Warfarin for Drug Therapy, Combination. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Oseltamivir 75 mg orally, twice daily for 4 days and once on Day 5.
Warfarin once daily, at a dose determined through titration by participants' usual hematologist.