At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
Brexpiprazole ODT 2mg with water +2 moredrug
Likely dose
Brexpiprazole ODT 2mg with waterfrom 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 Single Center, Open-label, Randomized, 3-arm, 3-way, Crossover Trial to Investigate the Bioequivalence of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets in Healthy Adult Males
In Brief
A Phase 1 clinical trial evaluating Brexpiprazole ODT 2mg with water, Brexpiprazole ODT 2mg without water, and 1 other intervention for Healthy Adult Male. Completed, enrolled 21 participants across 1 site.
Detailed Summary
To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional tablet 2 mg
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Adult Male
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
Enrollment StartMar 2019
First PostedApr 2019
Primary CompletionJun 2019
TodayJul 2026
First PostedApr 4, 2019
Enrollment StartMar 27, 2019
Primary CompletionJun 18, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.2 years ago
Interventions
Brexpiprazole ODT 2mg with waterdrug
Brexpiprazole ODT 2mg is administered with water.
Brexpiprazole ODT 2mg without waterdrug
Brexpiprazole ODT 2mg is administered without water.
Brexpiprazole conventional tablet 2mgdrug
Brexpiprazole conventional tablet 2mg is administered with water.