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A Bioequivalence Study of the Lu AA21004 20 mg and 2×10 mg Tablets

NCT03437564 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-06-27

Study results available
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Summary

The purpose of this study is to evaluate the bioequivalence of a single oral administration of a vortioxetine (Lu AA21004) 20 mg tablet in comparison with two of vortioxetine 10 mg tablets in Japanese healthy adult participants.

Conditions

  • Healthy Adult Participants

Interventions

DRUG

Vortioxetine

Vortioxetine tablet

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-02-16
Primary Completion
2018-04-13
Completion
2018-04-13

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

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 NCT03437564 on ClinicalTrials.gov