A study protocol may list midazolam even when the main research question concerns anticoagulants. In the DOAC-Child protocol, midazolam had a separate purpose as a probe of drug-metabolizing enzyme activity.
Hermann and colleagues planned a single oral cocktail containing microdoses of apixaban, rivaroxaban and edoxaban, with midazolam and yohimbine as probes. The protocol specified 10 micrograms of midazolam to help characterize CYP3A activity. Serial blood samples were planned to estimate the concentration-time profiles, with anticoagulant exposure as the primary pharmacokinetic outcome.
The protocol sets out what the investigators planned to administer, measure and compare. It does not report measured concentrations, treatment effects, or outcomes after therapeutic dosing. When reading a drug list from a study like this, check the purpose of each compound, the dose units and whether the document is a protocol or a report of completed experiments.
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