Why the study?
Does over-encapsulation of moxifloxacin alter its pharmacokinetics and pharmacodynamics compared to bare moxifloxacin in volunteers?
Population
22 volunteers
Comparison
Over-encapsulated moxifloxacin, bare… vs Over-encapsulated placebo
Design
RCT, randomized crossover, Placebo capsules and IV infusions were administered…
Authors
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Supports over-encapsulation of moxifloxacin as blinded active control in TQT studies; confirms bioequivalency without altering exposures or pharmacodynamics.
Does over-encapsulation of moxifloxacin alter its pharmacokinetics and pharmacodynamics compared to bare moxifloxacin in volunteers?
Over-encapsulation of moxifloxacin does not alter its pharmacokinetics or pharmacodynamics, supporting its use as a blinded active control in thorough QT studies.
Mason et al. (2010) studied this question.
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