Publications by authors named "Monia Crivelli"
Bioequivalence study of fluoxetine hydrochloride in healthy volunteers.
Arzneimittelforschung
November 2005
Article Synopsis
- Fluoxetine hydrochloride is a widely-used SSRI antidepressant, and this trial aimed to compare a new formulation of the drug to a reference product from Switzerland using 20 mg dispersible tablets.
- The study involved 30 healthy male volunteers and utilized advanced mass spectrometry to measure drug levels, finding that while fluoxetine and its metabolite, norfluoxetine, have different plasma profiles, both formulations were statistically shown to be bioequivalent.
- Results indicated that the peak concentrations and half-lives of both formulations were acceptable, with no significant differences in safety and tolerability, concluding that the new formulation is equivalent to the reference product.