NCT05416762

Single Dose Study to Evaluate Dose-proportionality of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

Single Dose Study to Evaluate Dose-proportionality of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets (5 mg, 10 mg and 20 mg) in Healthy Adult Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Seasons Biotechnology (Taizhou) Co., Ltd. · Industry
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An open label, randomized, three-period, three-treatment, six-sequence, crossover, balanced, single dose, dose proportionality study.

Detailed description

Single dose study to evaluate dose-proportionality of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets (5 mg, 10 mg and 20 mg) in healthy adult human subjects under fasting conditions. * To evaluate dose proportionality of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets (5 mg, 10 mg and 20 mg) in healthy, adult, human subjects under fasting conditions. * To monitor the safety and tolerability of the subjects. An open label, randomized, three-period, three-treatment, six-sequence, crossover, balanced, single dose, dose proportionality study.

Conditions

• Major Depressive Disorder (MDD

Interventions

Type	Name	Description
DRUG	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 5mg	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 5mg
DRUG	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 10mg	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 10mg
DRUG	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20mg	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20mg

Timeline

• Start date: 2022-09-19
• Primary completion: 2022-11-25
• Completion: 2022-11-25
• First posted: 2022-06-13
• Last updated: 2023-04-13

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study