A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta
Status:
Withdrawn
Trial end date:
2020-06-07
Target enrollment:
Participant gender:
Summary
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.