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:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT05416957
Brief Summary:
An open label, randomized, two-period, two-treatment \[Treatment A (Investigational product administration under fasting condition) vs Treatment B (Investigational product administration under fed condition)\], two-sequence, crossover, balanced, single dose oral food effect bioavailability study.
Detailed Description:
Single dose oral food effect bioavailability study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg in healthy adult human subjects under fasting and fed conditions.
* To compare and evaluate the oral bioavailability of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg in healthy, adult, human subjects under fasting and fed conditions.
* To monitor the safety and tolerability of the subjects. An open label, randomized, two-period, two-treatment \[Treatment A (Investigational product administration under fasting condition) vs Treatment B (Investigational product administration under fed condition)\], two-sequence, crossover, balanced, single dose oral food effect bioavailability study.
Study:
NCT05416957
Study Brief:
Protocol Section:
NCT05416957