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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Active Comparator: Cymbalta®- hard gelatinous capsule with delayed release microgranules ( Eli Lilly do Brasil Ltda) equivalent to 60 mg of duloxetine.
Experimental Drug: Duloxetine hydrochloride - hard gelatinous capsule with delayed release microgranules (Pfizer S.R.L - Argentina.) equivalent to 60 mg of duloxetine.
Area under the plasma concentration-time curve
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Up to 72 hours post dose
Maximum plasma concentrations (Cmax)
Time frame: Up to 72 hours post dose
Area under the plasma concentration-time curve from time zero extrapolated to infinite time
Time frame: Up to 72 hours post dose
Time to first occurrence of Cmax (Tmax)
Time frame: Up to 72 hours post dose
Terminal phase rate constant (kel)
Time frame: Up to 72 hours post dose
Number Of Participants with Clinically Significant Change From Baseline In Vital Signs
Following parameters will be analyzed for examination of vital signs: systolic and diastolic blood pressure, pulse rate, and axillary temperature.
Time frame: Baseline up to Day 28 after last dose of drug administration
Number Of Participants With Clinically Significant Change From Baseline in Laboratory Tests
Pre-defined criteria will be established to identify the values of potential clinical importance for the following laboratory tests: hematology, serum chemistry, and urinalysis, and electrocardiograms (ECG).
Time frame: Baseline up to Day 28 after last dose of drug administration
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