drugset / Trial / NCT02994394

A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects

NCT02994394

Phase 1 Completed 84 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2017-01-06
Primary completion
2017-02-28
Completion
2017-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolvaptan Small molecule 15 mg
Subject Tolvaptan Small molecule 30 mg

Indications

No indication recorded.