Trial intelligence / Profile preview

Bioequivalence of Tolvaptan OD vs Conventional Tablets

NCT02994394Phase 1Completed

Sponsor
Otsuka Pharmaceutical Co., Ltd.
Start
Jan 2017
Primary completion
Feb 2017
Modality
Small Molecules
Countries
1
01

Overview

Phase 1, randomised, open-label trial of tolvaptan in hyponatremia and autosomal dominant polycystic kidney disease (ADPKD) (6 arms), sponsored by Otsuka Pharmaceutical Co., Ltd. Primary endpoints: Maximum Plasma Concentration at 16 hours and Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at 16 hours. Started Jan 2017; status: completed.

02

Drugs

tolvaptan
03

Conditions

hyponatremiaautosomal dominant polycystic kidney disease (ADPKD)

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