Study of Excretion Balance and Pharmacokinetics of [14C]-Sodium Valproate (3.7 MBq) in Healthy Postmenopausal or Permanently Sterile Female Subjects

Summary

Primary Objectives: * To determine the excretion balance and systemic exposure of radioactivity after oral administration of \[14C\]-sodium valproate (VPA) . * To determine the pharmacokinetics of sodium VPA and metabolite(s) and its contribution to the overall exposure of radioactivity. * To collect samples in order to determine the metabolic pathways of sodium VPA and identify the chemical structures and main excretion route of the main metabolites. Secondary Objective: To assess the clinical and biological tolerability of oral solution of sodium VPA.

Timeline

Start

2018-10-05

Primary completion

2019-04-11

Completion

2019-04-11

Drugs

Indications