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Food Effect Bioavailability Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

NCT05416957 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-04-13

No results posted yet for this study

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.

Conditions

  • Major Depressive Disorder (MDD)

Interventions

DRUG

Vortioxetine Hemihydrobromide Orally Disintegrating Tablets

Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 20mg administration under fasting condition

Sponsors & Collaborators

  • Seasons Biotechnology (Taizhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Minesh Patel, 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
2022-09-18
Primary Completion
2022-10-27
Completion
2022-10-27
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 NCT05416957 on ClinicalTrials.gov