Karessa Pharma Holding AB announces today that the first patient is dosed in the company's clinical study with K-03 Vardenafil buccal film
Today, the dosing of healthy volunteers begins in Karessa's clinical trial K-03/1 buccal film. The study will last for five weeks and is planned to be completed on 15th of December 2017.The study is a Phase I, open, randomized, single-center study on healthy male subjects in order to determine the PK profile in the body (pharmacokinetic profile) of Vardenafil given as K-03/1 buccal film. The study consists of comparing the PK profile of four different variants of K-03/1 buccal film. Except for the evaluating of PK profile, the safety and tolerability of Karessa's K-03/1 buccal film will