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Food Effect Bioavailability Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

Major Depressive Disorder (MDD) Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05416957
Study type Interventional
Source Seasons Biotechnology (Taizhou) Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date September 18, 2022
Completion date October 27, 2022
View Details
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