Pharmacokinetic measurements
In each treatment period, for the determination of plasma concentrations
of zamicastat and its metabolites, venous blood samples (6 mL) were
drawn into lithium heparin tubes, 30 minutes after breakfast on day -1
and at pre-dose (within 10 minutes) on days 3, 6, 8, and 10. Plasma
concentrations of zamicastat and its metabolites BIA 5-453 and BIA 5-961
were determined by SYNLAB Analytics & Services Switzerland AG
(Sternenfeldstrasse 14 CH-4127 Birsfelden, Switzerland), in accordance
with the applicable principles of GLP, using a previously validated
LC-MS/MS analytical method.
The pharmacokinetics analysis set (PK population) included all subjects
who had received at least one dose of zamicastat without major protocol
deviation and had at least one valid evaluable post-dose plasma
zamicastat concentration.