Clinical Trials Directory

Trials / Completed

CompletedNCT03254108

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

A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group Comparison Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
61 (actual)
Sponsor
Otsuka Pharmaceutical Co., Ltd. · Industry
Sex
All
Age
20 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGOPC-61815 injection 2mgOnce daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
DRUGOPC-61815 injection 4mgOnce daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
DRUGOPC-61815 injection 8mgOnce daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
DRUGOPC-61815 injection 16mgOnce daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
DRUGTolvaptan tablet 15mgOnce daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.

Timeline

Start date
2017-11-06
Primary completion
2018-04-14
Completion
2018-04-24
First posted
2017-08-18
Last updated
2021-07-28
Results posted
2021-07-28

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT03254108. Inclusion in this directory is not an endorsement.