Pharmacokinetics and Safety of Vortioxetine in the Chinese Population

• DOI: 10.1007/s12325-019-01092-4
• Publication Date: 2019-09-24T08:03:08Z
• Authors: Jia Miao; Gang Wang; Jie Hou; Johan Areberg; Yan Zhao; Astrid-Maria Højer; Anders Ettrup
• Keywords: Vortioxetine; Chinese population

Major depressive disorder (MDD) is associated with a significant burden of disease in China. Awareness and better access to treatments could help alleviate the MDD. Because variations have been observed pharmacokinetics (PK) antidepressants across different races ethnicities, evaluation clinical pharmacology vortioxetine diverse populations remains important assess potential need for dose adjustments. Data were pooled from two phase I open-label PK studies healthy Chinese subjects, one III double-blind noninferiority study patients MDD describe safety data vortioxetine. Doses these ranged 10 mg (single dose) 20 (multiple daily doses). A population analysis was conducted using nonlinear mixed-effect modeling. In total, 186 individuals included analysis: 79 subjects 107 No clinically differences between previous non-Chinese populations. generally lower weight compared population, exposures 19% 18% higher than (for maximum plasma concentration area under concentration–time curve, respectively), which not considered relevant. high prevalence pruritus (56% overall); however, this reflected (0.8%). The parameters comparable subjects. Overall, no new concerns raised among population. On basis analysis, tolerability profile expected be that H. Lundbeck A/S, Valby, Denmark. NCT01676571.