The objective of this study is to evaluate the comparative bioavailability between granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets (Roche, USA), after a single-dose in health subjects under fed conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
80
2 x 1 mg, single dose non-fasting
2 x 1 mg, single dose non-fasting
Pharma Medica Research Inc
Toronto, Ontario, Canada
Cmax (Maximum Observed Concentration)
Bioequivalence based on Cmax
Time frame: Blood samples collected over 72 hour period
AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]
Bioequivalence based on AUC0-inf
Time frame: Blood samples collected over 72 hour period
AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]
Bioequivalence based on AUC0-t
Time frame: Blood samples collected over 72 hour period
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