NCT05417087

Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg and 'Trintellix' (Vortioxetine) Tablets 20 mg in Healthy Adult Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (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 \[Treatment A (test product administered without water), Treatment B (test product administered with water) and Treatment C (Reference product administered with water)\], six-sequence, crossover, balanced, single dose oral bioequivalence study.

Detailed description

Single dose oral bioequivalence study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg and 'Trintellix' (Vortioxetine) Tablets 20 mg in healthy adult human subjects under fasting conditions. * To compare and evaluate the oral bioavailability of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg (administered without water and with water) with that of 'Trintellix' (Vortioxetine) Tablets 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 \[Treatment A (test product administered without water), Treatment B (test product administered with water) and Treatment C (Reference product administered with water)\], six-sequence, crossover, balanced, single dose oral bioequivalence study.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20 mg equivalent to 20 mg of Vortioxetine
DRUG	Vortioxetine Hydrobromide Tablets	Vortioxetine Hydrobromide Tablets 20mg

Timeline

• Start date: 2022-06-27
• Primary completion: 2022-09-02
• Completion: 2022-09-02
• First posted: 2022-06-14
• Last updated: 2023-04-13

Locations

1 site across 1 country: India