The purpose of this study is to investigate the effect of food on the pharmacokinetics of a single 800 mg oral dose of BIA 2-093 in healthy volunteers.
Single centre, open label, randomized, two-way crossover study in 12 healthy male volunteers. The study consisted of 2 periods separated by a washout period of 14 days or more. On each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration of BIA 2-093
Time frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
Time of Occurrence of Cmax (Tmax)
Time of occurrence of Cmax of BIA 2-093
Time frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification (AUC0-t)
Area under the plasma concentration versus time curve from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t) of BIA 2-093
Time frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-oo)
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-oo) of BIA 2-093
Time frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose
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