Healthy Clinical Trial
Official title:
A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF DULOXETINE HYDROCHLORIDE HARD GELATINOUS CAPSULE WITH DELAYED RELEASE MICROGRANULES (60 MG; PFIZER S.R.L - ARGENTINA) COMPARED WITH CYMBALTA(REGISTERED) ( 60 MG; ELI LILLY DO BRASIL LTDA) IN HEALTHY MALE RESEARCH SUBJECTS UNDER FASTED CONDITIONS
In Brazil, duloxetine is currently available as hard gelatinous capsule with delayed release
microgranules for oral administration containing enteric-coated pellets of 33.7, or 67.3 mg
of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine (Cymbalta®),
respectively.
The Sponsor has developed a hard gelatinous capsule with delayed release microgranules
formulation containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride
equivalent to 30, or 60 mg of duloxetine, respectively.
The purpose of this study is to verify through a single dose study, if the test formulation
of duloxetine (60 mg) is bioequivalent to the reference formulation (Cymbalta® 60 mg) when
administered with the same dosage and under fasted conditions in healthy male research
subjects.
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