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Mass Balance and PK of (14C)-OPC-61815 in Healthy Japanese Men
NCT04182958Phase 1Completed
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Start
- Nov 2019
- Primary completion
- Dec 2019
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, open-label, single-arm trial of tolvaptan in edema secondary to heart failure and heart failure (HF), sponsored by Otsuka Pharmaceutical Co., Ltd. Primary endpoints: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form at 48 hours, Maximum Peak Concentration (Cmax) - Plasma OPC-61815 Free Form at 48 hours and 7 more. Started Nov 2019; status: completed.
02
Drugs
tolvaptan
03
Conditions
edema secondary to heart failureheart failure (HF)
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