NCT06273254

A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions

A Bioequivalence Study of Two Formulations of Sacubitril/Valsartan 49 mg/51 mg Film-coated Tablets in Healthy Thai Subjects Under Fasting Conditions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Primary objective is to is to evaluate the bioequivalence of two formulations

Detailed description

To evaluate the bioequivalence of two formulations of sacubitril/valsartan 49 mg/51 mg film coated tablets, Entresto® (Reference) and Sacubitril and Valsartan Tablets 49mg/51mg (Test), after a single oral dose administration in healthy Thai subjects under fasting conditions

Conditions

• Bioequivalence Study

Interventions

Type	Name	Description
DRUG	Sacubitril and Valsartan Tablets 49mg/51mg	Each tablet contains Sacubitril 49 mg and Valsartan 51 mg
DRUG	Entresto® (Sacubitril and Valsartan Tablets 49mg/51mg)	Each tablet contains 48.6 mg sacubitril and 51.4 mg valsartan as sodium salt complex

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-05-01
• Completion: 2024-09-01
• First posted: 2024-02-22
• Last updated: 2024-02-22

Locations

1 site across 1 country: Thailand