At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
OPC-34712drug
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 Single-center, Open-label, Randomized, Three-way, Crossover Trial to Evaluate the Bioavailability of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets Relative to Brexpiprazole (OPC-34712) Conventional Tablets in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating OPC-34712 for Healthy Adult Male. Completed, enrolled 18 participants across 1 site.
Detailed Summary
The ratios of the geometric means of the ODT formulation to those of the reference formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of brexpiprazole (OPC-34712)).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Adult Male
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartSep 2016
Primary CompletionNov 2016
TodayJul 2026
First PostedAug 23, 2016
Enrollment StartSep 27, 2016
Primary CompletionNov 27, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.9 years ago
Interventions
OPC-34712drug