Overview

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

Status:
Completed

Trial end date:
2019-04-11

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Sanofi

Treatments:

Valproic Acid