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

Epilepsy Clinical Trial

Official title:
An Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-Sodium Valproate (3.7 MBq) in Healthy Postmenopausal or Permanently Sterile Female Subjects

Clinical Trial 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.

Clinical Trial Description

Total study duration is 3 to 10 weeks, including a screening period of 8 to 28 days, treatment period of up to 15 days and a follow-up and end of study of up to 4 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03681158
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date October 5, 2018
Completion date April 11, 2019
View Details
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