Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and Bystolic®20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were separated by a washout period of 11 days.
An Open Label, Randomized, 2- Period, 2 -Treatment, 2 -Sequence, Crossover, Single- dose Bioequivalence study of Nebivolol Tablets containing Nebivolol 20 mg (Test Formulation, Torrent Pharmaceuticals Ltd., India) Versus Bystolic® 20 mg Tablets containing Nebivolol 20 mg (Reference, Forest Pharmaceuticals Ltd., USA) in Healthy Volunteers Under Fed Condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Cmax
Time frame: pre-dose to 72 hours post-dose
AUC
Time frame: pre-dose to 72 hours post-dose
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