At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 84 enrolled
Drug / intervention
OPC-41061drug
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 Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects
In Brief
A Phase 1 clinical trial evaluating OPC-41061 for Healthy Adult Male. Completed, enrolled 84 participants across 1 site.
Detailed Summary
To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15 and 30 mg in healthy adult male subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Adult Male
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartJan 2017
Primary CompletionFeb 2017
TodayJul 2026
First PostedDec 15, 2016
Enrollment StartJan 6, 2017
Primary CompletionFeb 28, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.5 years ago
Interventions
OPC-41061drug