Key result
Step-wise duloxetine dose escalation evaluated for effects on the QT interval in healthy females.
Why the study?
Controversy exists regarding the optimal study design to evaluate a drug's effect on the QT interval due to confounding factors like drug interactions, metabolites, and tolerability at high dosages.
Does duloxetine affect Fridericia's corrected QT interval in healthy females?
Population
Healthy females
Comparison
Duloxetine step-wise dosing vs placebo and moxifloxacin positive control
Design
Randomized, double-blind, placebo-controlled, two-way crossover study
Follow-up
12-hour dosing interval
Authors
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Informs duloxetine dosing strategies for QT assessment; extends pharmacokinetic methods to optimize definitive cardiac safety trials.
RCT
double-blind
randomized
Does duloxetine affect Fridericia's corrected QT interval in healthy females?
Preliminary studies defining tolerability and pharmacokinetics can optimize the design of definitive QT studies for drugs like duloxetine.
Derby et al. (2005) conducted an RCT in Healthy. Duloxetine vs. Placebo and moxifloxacin was evaluated on Fridericia's corrected QT interval. A randomized, double-blind crossover study design was developed to evaluate the effect of step-wise dose escalation of duloxetine on the QT interval in healthy females.
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