Phase 1Status unknown
A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
A Bioequivalence Study of Two Formulations of Sacubitril/Valsartan 97 mg/103 mg Film-coated Tablets in Healthy Thai Subjects Under Fasting Conditions
- Sponsor
- Viatris Inc. (Industry)
- Enrollment
- 48 planned
- Conditions
- Chronic Heart Failure
- Interventions
- Sacubitril and Valsartan Tablets 97mg/103mg; Entresto (Sacubitril and Valsartan Tablets 97mg/103mg)
- Ages
- adults
- Registry
- NCT06266988
Full record on ClinicalTrials.gov
From the registry
Primary objective is to is to evaluate the bioequivalence of two formulations
Primary outcomes
- Bioequivalence based on Cmax period (using the validated Phoenix® WinNonlin® software)
- Bioequivalence based on AUC period (using the validated Phoenix® WinNonlin® software)
History
Study completion
Primary completion
Started
Registered