Karessa has now finalized the reformulation of project K03, Vardenafil, Karessa, a decision made spring 2018.
The development has been documented in preclinical studies. A comparison between Vardenafil, Karessa, and vardenafil tablet in corresponding doses resulted in Cmax(maximum plasma concentration) the ratio 0.91 and for AUC (Area Under the curve) 1.03. These are the essential pharmacokinetic parameters for pharmaceutical registration and in comparison, to reference (tablet), the values should be within ±20% limit (the ratio 0,8-1,2)
The company will now enter next phase in further