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Hoffmann, R. A wiki for the life sciences where authorship matters. Nature Genetics (2008)
 
 
 
 
 

Open-label, nonrandomized study of the effects of gatifloxacin on the pharmacokinetics of midazolam in healthy male volunteers.

STUDY OBJECTIVE: To confirm findings from an in vitro study that showed gatifloxacin did not substantially inhibit cytochrome P450 ( CYP) 3A4 model substrate metabolism. DESIGN: Open-label, nonrandomized trial. SETTING: Clinical pharmacology unit. SUBJECTS: Fourteen healthy adult men. INTERVENTION: Using midazolam probe methodology, the clearance of midazolam in the presence of multiple-dose gatifloxacin was evaluated. MEASUREMENTS AND MAIN RESULTS: Typical steady-state concentrations of gatifloxacin 400 mg once/day had no effect on midazolam clearance, and gatifloxacin pharmacokinetics were unaffected by midazolam. All doses of both agents were well tolerated. CONCLUSION: Data from this in vivo trial support in vitro experience with gatifloxacin and suggest that interactions are unlikely between gatifloxacin and drugs that are metabolized by CYP3A.[1]

References

  1. Open-label, nonrandomized study of the effects of gatifloxacin on the pharmacokinetics of midazolam in healthy male volunteers. Grasela, D.M., LaCreta, F.P., Kollia, G.D., Randall, D.M., Uderman, H.D. Pharmacotherapy (2000) [Pubmed]
 
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