To investigate the steady-state pharmacokinetics of once-daily and twice-daily regimens of BIA 2-093 and twice-daily regimen of Oxcarbazepine (Trileptal®) in healthy subjects and to assess the tolerability of such regimens in healthy subjects.
Single centre, open-label, randomised, three-way crossover study in 12 healthy volunteers. The study consisted of three 8-day treatment periods separated by washout periods of 10-15 days. On each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 900 mg once-daily (od), BIA 2-093 450 mg twice-daily (bid), or Oxcarbazepine (Trileptal®) 450 mg bid.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
BIAL - Portela & Cª S.A. - Human Pharmacology Unit (UFH)
S. Mamede Do Coronado, Trofa, Portugal
Cmax - Maximum Observed Plasma Drug Concentration
Cmax - maximum observed plasma drug concentration for BIA 2-093 metabolites: BIA 2-194 BIA 2-195 Oxcarbazepine
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose
AUC - Area Under the Plasma Concentration Versus Time Curve
AUC - Area Under the Plasma Concentration Versus Time Curve for BIA 2-093 metabolites: BIA 2-194 BIA 2-195 Oxcarbazepine
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose
Number of of Subjects Reporting at Least One Adverse Event
Number of of subjects reporting at least one adverse event.
Time frame: 8 weeks
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