A study was carried out on 18 healthy volunteers of both sexes, aged between 22 and 40 years, with the aim to evaluate the bioequivalence of two zopiclone tablet preparations dosed 7.5 mg/tablet - Neurolil® (Novaquimica - Sigma Pharma, Brasil) and Imovane® (Rhone-Poulenc Rorer, Italy). A single oral dose of 2 tablets of the two drugs was administered according to a controlled, randomized, crossover schedule. This dose corresponds to 15 mg of zopiclone. A sensitive reverse-phase, high performance liquid chromatographic (HPLC) method has been developed to determine the amount of zopiclone in plasma samples. The experimental procedure consisted of the extraction of the drug with dichloromethane from alkalinized plasma sample. The organic phase was separated, evaporated to dryness and the residue was dissolved in mobile phase and analysed by HPLC. The results evaluated by statistical methods showed that the two formulations are bioequivalent.
Comparative bioavailability of two preparations of zopiclone [Estudo de bioequivalencia comparada de duas preparacoes de zopiclone]
Drago F.
1999-01-01
Abstract
A study was carried out on 18 healthy volunteers of both sexes, aged between 22 and 40 years, with the aim to evaluate the bioequivalence of two zopiclone tablet preparations dosed 7.5 mg/tablet - Neurolil® (Novaquimica - Sigma Pharma, Brasil) and Imovane® (Rhone-Poulenc Rorer, Italy). A single oral dose of 2 tablets of the two drugs was administered according to a controlled, randomized, crossover schedule. This dose corresponds to 15 mg of zopiclone. A sensitive reverse-phase, high performance liquid chromatographic (HPLC) method has been developed to determine the amount of zopiclone in plasma samples. The experimental procedure consisted of the extraction of the drug with dichloromethane from alkalinized plasma sample. The organic phase was separated, evaporated to dryness and the residue was dissolved in mobile phase and analysed by HPLC. The results evaluated by statistical methods showed that the two formulations are bioequivalent.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
