Open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of subjects with various degrees of renal function based on creatinine clearance
This was an open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of subjects with various degrees of renal function based on creatinine clearance (stages of renal function according to the Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products Guidelines) for the evaluation of pharmacokinetics in patients with impaired renal function. The trial commenced with Groups 1 and 2. An interim safety evaluation was conducted and, as there were no safety concerns, the trial continued with Groups 3 and 4. After another interim safety evaluation with the data from Groups 3 and 4, the trial commenced with Group 5.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Farmovs-Parexel
Bloemfontein, Bloemfontein, South Africa
Cmax - Peak Plasma Concentration
BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites
Time frame: pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.
AUC(0-12h) - AUC From Time Zero to 12h
BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites AUC - area under the plasma concentration versus time curve
Time frame: pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.
Tmax (hr) - Time at Which Cmax Occurred
BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites Cmax - maximum observed plasma drug concentration
Time frame: pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.
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