This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy adult volunteers under fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
26
90 mg Capsules
90 mg Capsules
PRACS Institute, Ltd.
Fargo, North Dakota, United States
Cmax of Fluoxetine.
Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).
Time frame: Blood samples collected over a 25 day period.
AUC0-t of Fluoxetine.
Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Time frame: Blood samples collected over a 25 day period.
AUC0-inf of Fluoxetine.
Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).
Time frame: Blood samples collected over a 25 day period.
Cmax of Norfluoxetine.
Informational comparison of Cmax values for the metabolite Norfluoxetine.
Time frame: Blood samples collected over a 25 day period.
AUC0-t of Norfluoxetine.
Informational comparison of AUC0-t values for the metabolite Norfluoxetine.
Time frame: Blood samples collected over a 25 day period.
AUC0-inf of Norfluoxetine.
Bioequivalence based on Norfluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).
Time frame: Blood samples collected over a 25 day period.
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