NCT05416957

Food Effect Bioavailability Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Seasons Biotechnology (Taizhou) Co., Ltd. · Industry
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20mg administration under fasting condition

Timeline

• Start date: 2022-09-18
• Primary completion: 2022-10-27
• Completion: 2022-10-27
• First posted: 2022-06-14
• Last updated: 2023-04-13

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study