drugset / Trial / NCT00603317
Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid
RandomizedCrossoverQuadruple-blindTreatment
Summary
Several case reports indicate that the use of the antibiotic combination amoxicillin and clavulanic acid (AM-CLAVAC) can interact with warfarin pharmacodynamics. However, fever per se might also be responsible of these warfarin overdose reports, as well as the use of high dose paracetamol. The aim of the present study is to determine if AM-CLAVAC can increase the pharmacodynamics of warfarin among patients at steady state Double blinded cross over controlled study vs placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3 and a stable INR and a stable dose.
Timeline
- Start
- 2008-03
- Primary completion
- 2010-03
- Completion
- 2010-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 2 g | — |
| Subject | clavulanic acid | Small molecule | 125 mg | — |