Randomised bioequivalence clinical trial of sacubitril/valsartan 49 mg/51 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions in crossover replicated design.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505237-27-00

Acronym

N-SACVAL-23-278

Enrollment

Registered

2023-05-24

Start date

2023-06-02

Completion date

2023-07-20

Last updated

2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Brief summary

Sacubitril AUC0-t, Sacubitril Cmax, Valsartan AUC0-t, Valsartan Cmax

Detailed description

Sacubitril AUC0-∞, Sacubitril Tmax, Sacubitril residual area, Valsartan AUC0-∞, Valsartan Tmax, Valsartan residual area

Interventions

DRUGEntresto 49 mg/51 mg film-coated tablets

DRUGSacubitrilo/valsartán Normon 49 mg/ 51 mg comprimidos recubiertos con película

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Sacubitril AUC0-t, Sacubitril Cmax, Valsartan AUC0-t, Valsartan Cmax	—

Secondary

Measure	Time frame
Sacubitril AUC0-∞, Sacubitril Tmax, Sacubitril residual area, Valsartan AUC0-∞, Valsartan Tmax, Valsartan residual area	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026