Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT03681158
Brief 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.
Detailed 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:
NCT03681158
Study Brief:
Protocol Section:
NCT03681158