Randomised bioequivalence clinical trial of sacubitril/valsartan 97 mg/103 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

CTIS2022-503083-32-00

Acronym

N-SACVAL-22-275

Enrollment

Registered

2023-03-07

Start date

2023-03-08

Completion date

2023-04-26

Last updated

2023-03-07

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 97 mg/103 mg film-coated tablets

DRUGSacubitrilo/valsartán Normon 97 mg/ 103 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