Ciudad Autonoma De Buenos Aire, Argentina Clinical Trials

Primary objective is to evaluate the effect of various food compositions on the PK of nifurtimox after a single oral dose (120 mg) administered under 3 types of fed conditions (low fat, dairy products, and high calorie and high fat), as well as fasted conditions, to assess relative bioavailability.It was ...

Three-way bridge phase 1 trial. It is conducted in healthy, male adult subjects, it is single-dose, double-blind, parallel groups, randomized and balanced. Blood samples are collected up to 90 days, to dermine serum drug concentration and anti-drug antibodies. Safety and tolerabilty is also evaluated.