Bioavailability and Bioequivalence Study of Gabapentin » książka
Bioavailability and Bioequivalence Study of Gabapentin
ISBN-13: 9783659347016 / Angielski / Miękka / 2013 / 72 str.
The present study has been undertaken with following objectives: To assess the bioequivalence of Gabapentin 600 mg Tablet (Test formulation, Torrent Pharmaceuticals Ltd., India) versus Neurontin(r) 600mg Tablet (Reference formulation, Pfizer, Brazil) in healthy human volunteers after administration of single Tablet of either test or reference formulation under fasting condition. The secondary objective was to evaluate the safety of Gabapentin in healthy human volunteers on the basis of clinical and laboratory examinations (at the beginning and at the end of the trial) and registration of adverse events and/or adverse drug reactions in healthy human volunteers after administration of single tablet of either test or reference formulation under fasting conditions."
The present study has been undertaken with following objectives: • To assess the bioequivalence of Gabapentin 600 mg Tablet (Test formulation, Torrent Pharmaceuticals Ltd., India) versus Neurontin® 600mg Tablet (Reference formulation, Pfizer, Brazil) in healthy human volunteers after administration of single Tablet of either test or reference formulation under fasting condition. • The secondary objective was to evaluate the safety of Gabapentin in healthy human volunteers on the basis of clinical and laboratory examinations (at the beginning and at the end of the trial) and registration of adverse events and/or adverse drug reactions in healthy human volunteers after administration of single tablet of either test or reference formulation under fasting conditions.
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