Healthy Clinical Trial
Official title:
Dicloxacillin: Clinical Relevance of Drug-drug Interactions by Induction of Drug Metabolizing Enzymes.
This trial is conducted as a cocktail-study namely an open-label, randomized, two-sequence, two-period crossover, cocktail study where a combination of cocktail-drugs is used to illustrate whether or not, or to what degree dicloxacillin affects the level of activity of the 5 most important CYP enzymes and therefore plays a potentially decisive role in serious drug-drug interactions.
Given knowledge explains dicloxacillin and the drug warfarin to be a potential dangerous drug
drug interaction because the effects of warfarin is downregulated to a degree as to where it
might cause patients to have thrombotic events.
A potential explanation to this is namely dicloxacillin increases the activity of certain
drug metabolising enzymes metabolising warfaring which in turn decreases the concentration of
the drug in the blood and the therapeutic effect.
Cocktail study is the golden standard to investigate as to whether there is changes is P450
enzymes as a result of drug-drug interactions.
The cocktail consists of Midazolam, omeprazole, tolbutamide, caffein and dextromethorphan
which is well known markers for these enzymes. These markers are safe, have specific (enzyme)
metabolism and has been used in several studies with no Serious Adverse reactions reported.
By measuring the Concentration of the drug and its metabolites in plasma / Urine before and
after treatment with dicloxacillin we will estimate AUC (area under the curve) and test our
hypothesis/primary end point of whether there is change in AUC for Tolbutamide (CYP2C9)
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