NOVARTIS CONSUMER HEALTH SCHWEIZ AG

The primary objective of this study was to demonstrate the non-inferiority of diclofenac diethylamide (DDEA) 2.32% compared to DDEA 1.16% in relieving pain in acute ankle sprains.

To register Nicotinell chewing gum in China, the bioavailability (BA) of nicotine in Nicotinell chewing gum 4mg mint flavor and Nicotinell chewing gum 4mg fruit flavor will be investigated, and the systemic absorption rate and extent of nicotine after a single oral administration in healthy Chinese adult male smokers will be evaluated to be equivalent to a Nicorette chewing gum reference formulation. In addition, the safety profile will be evaluated and summarized.

To register Nicotinell chewing gum in China, the bioavailability (BA) of nicotine in Nicotinell chewing gum 2mg mint flavor and Nicotinell chewing gum 2mg fruit flavor will be investigated, and the systemic absorption rate and extent of nicotine after a single oral administration in healthy Chinese adult male smokers will be evaluated to be equivalent to a Nicorette chewing gum reference formulation. In addition, the safety profile will be evaluated and summarized.