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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |