Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as sodium valproate
valproate · 1 trial · 1 indication
Fractional and cumulative percentage of radioactive dose excreted in urine and feces
key metabolite(s) of sodium valproate will be assessed in plasma, urine and feces.
Maximum plasma or blood concentration observed
Time to reach Cmax (tmax)
Area under the plasma concentration versus time curve calculated from time zero to the real time, tlast (time corresponding to the last concentration above the limit of quantification, Clast (AUClast)
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
Terminal half-life associated with the terminal slope (λz) (t1/2z) in plasma, blood radioactivity and plasma VPA
Blood to plasma radioactivity ratio calculated at each time point
RCmax is calculated as Cmax(VPA)/Cmax (radioactivity)
RAUC is calculated as AUC(VPA)/AUC (radioactivity)
| Arm | Type | Description |
|---|---|---|
| sodium valproate | EXPERIMENTAL | Single oral dose of sodium valproate containing \[14C\]-sodium VPA |
| Name | Type | Description |
|---|---|---|
| sodium valproate | DRUG | Pharmaceutical form:Powder for oral solution reconstituted with water Route of administration: Oral |
Inclusion criteria : * Female subjects, between 30 and 60 years of age, inclusive. * Body weight between 40.0 and 90.0 kg, inclusive, body mass index between 18.0 and 30.0 kg/m2, inclusive. * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical...