Trial intelligence / Profile preview

Bioequivalence of Generic Sacubitril/Valsartan vs Entresto in Healthy Volunteers

NCT06248112Phase 1Not yet recruiting

Sponsor
Bio-innova
Start
May 2024
Primary completion
Jun 2024
Modality
Small Molecules
01

Overview

Phase 1, randomised, open-label trial of sacubitril + valsartan in heart failure (HF) (2 arms), sponsored by Bio-innova. Primary endpoints: Area under the plasma concentration-time curve from time zero to the last measurable concentration at 48 hours, Maximal measured plasma concentration at 48 hours and 1 more. Planned start May 2024; status: not yet recruiting.

02

Drugs

sacubitril + valsartan
03

Conditions

heart failure (HF)

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