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news.Eurand has reported positive results of a pilot pharmacokinetic study of EUR-1025, the company's proprietary once-a-day or QD oral formulation of ondansetron hydrochloride.
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Ondansetron is marketed under the brand name Zofran by GlaxoSmithKline for the treatment and prevention of chemotherapy-induced nausea and vomiting. The study was designed to compare the pharmacokinetic profile of a QD oral formulation of EUR-1025 to an 8mg tablet of Zofran dosed twice per day. The study achieved its goal of producing a formulation with a similar pharmacokinetic profile which was bioequivalent when normalized for dose.
The study was conducted using healthy volunteers. Plasma ondansetron levels were measured and analyzed for standard pharmacokinetic parameters. The extended release properties of the proprietary technology used resulted in a QD formulation with comparable delivery of drug to reference. There were no serious adverse events and all of the subjects completed the study.