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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 is bioequivalent to the reference formulation (Cymbalta®) when administered with the same dosage and under fed conditions in healthy male research subjects.
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0 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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