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Dec 23, 2013 | Daniel A. Spyker, PhD, MD, Polina Voloshko, MD, Eugene R. Heyman, PhD, and James V. Cassella, PhD

Loxapine Delivered as a Thermally Generated Aerosol Does Not Prolong QTc in a Thorough QT/QTc Study in Healthy Subjects

Loxapine, which was introduced more than 35 years ago in the US, Canada, and Europe, has a well-established efficacy and safety profile in the treatment of schizophrenia. Although it was approved by the FDA, a thorough QT/QTc study had not been conducted for loxapine.

To establish the effects of inhaled loxapine on the QTc interval in a randomized, placebo-controlled, double-blind crossover trial, 48 healthy volunteers received a single inhaled placebo or 10mg loxapine to test the effects.

Download the publication to discover the key findings of the study, including:

  • Study design and medication
  • ECG recording, analysis and interpretation
  • Statistical analysis
  • Relationship between QT interval and loxapine
Download