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Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

NCT05417087 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-04-13

No results posted yet for this study

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.

Conditions

  • Major Depressive Disorder (MDD)

Interventions

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

Sponsors & Collaborators

  • Seasons Biotechnology (Taizhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Mayur Soni, Ph.D. · Cliantha Research Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-27
Primary Completion
2022-09-02
Completion
2022-09-02

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05417087 on ClinicalTrials.gov