This study compared the relative bioavailability (rate and extent of absorption) of the test Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited to the reference Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd., distributed by Parke Davis, division of Warner-Lambert Co. in 28 healthy, adult subjects (21 males and 7 females) under fasting conditions using randomized, two-way crossover design.
A single oral dose of the test or reference product was administered to the volunteers on two separate occasions under fasting conditions with at least a 7 day washout between doses. Food and fluid intake were controlled during each confinement period. A total of twenty eight (28) healthy subjects (21 males and 7 females) were enrolled in the study of which twenty seven (27) subjects completed the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
28
PRACS Institute Ltd.
Fargo, North Dakota, United States
Bioequivalence
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