At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Vortioxetinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-Label, 2×2 Crossover Phase 1 Study to Evaluate the Bioequivalence of Single Oral Dose of Lu AA21004 20 mg Tablet and 2× Lu AA21004 10 mg Tablets in Healthy Adult Subjects
In Brief
A Phase 1 clinical trial evaluating Vortioxetine for Healthy Adult Participants. Completed, enrolled 28 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Adult Participants
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartFeb 2018
First PostedFeb 2018
Primary CompletionApr 2018
TodayJul 2026
First PostedFeb 19, 2018
Enrollment StartFeb 16, 2018
Primary CompletionApr 13, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.4 years ago
Interventions
Vortioxetinedrug
Vortioxetine tablet