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

NCT05416762 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-13

No results posted yet for this study

Summary

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

Conditions

  • Major Depressive Disorder (MDD

Interventions

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

Sponsors & Collaborators

  • Seasons Biotechnology (Taizhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kanuji Thakor, 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
2022-09-19
Primary Completion
2022-11-25
Completion
2022-11-25
FDA Drug
Yes

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 NCT05416762 on ClinicalTrials.gov