The aim of this study was to compare the rate and extent of absorption of the test product of pregabalin 300 mg hard capsule (manufactured by West Pharma, S.A. for Tecnimede, Sociedade Técnico-Medicinal S.A., Sintra, Portugal) with the reference product, Lyrica® 300 mg hard capsule (manufactured by Pfizer GmbH, Germany), administered as a 1 × 300 mg capsule, under fasting conditions. This was a single-center, randomized, single-dose, laboratory-blinded, open-label, two-period, two-sequence, crossover bioequivalence study in healthy volunteers.
Subjects were assigned to one of two treatment sequences. No food was allowed from at least 10 h before dosing until at least 4 h after dosing, after which a standardized lunch was served. A supper and a light snack were also served at appropriate times thereafter, but not before 9 h after dosing. With the exception of the 240 mL of water administered at the time of dosing, fluids were not permitted from 1 h before dosing to 1 h after dosing; water was permitted ad libitum at all other times.
The treatment periods were separated by a washout period of 7 days.
Subjects were assigned to one of two treatment sequences. No food was allowed from at least 10 h before dosing until at least 4 h after dosing, after which a standardized lunch was served. A supper and a light snack were also served at appropriate times thereafter, but not before 9 h after dosing. With the exception of the 240 mL of water administered at the time of dosing, fluids were not permitted from 1 h before dosing to 1 h after dosing; water was permitted ad libitum at all other times.
The treatment periods were separated by a washout period of 7 days.