drugset / Trial / NCT03254108

Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

NCT03254108

Completed 61 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with congestive heart failure.

Timeline

Start
2017-11-06
Primary completion
2018-04-14
Completion
2018-04-24

Drugs

EvaluationDrugModalityDoseRoute
Subject OPC-61815 Unknown 2 mg Intravenous
Subject OPC-61815 Unknown 4 mg Intravenous
Subject OPC-61815 Unknown 8 mg Intravenous
Subject OPC-61815 Unknown 16 mg Intravenous
Comparator Tolvaptan Small molecule 15 mg Oral