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A Bioequivalence Study of Two Formulations of Sacubitril/Valsartan 24 mg/26 mg Film-coated Tablets in Healthy Thai Subjects Under Fasting Conditions
To evaluate the bioequivalence between two formulations of sacubitril/valsartan 24 mg/26 mg film-coated tablets, Entresto 50 mg (Reference) and Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg (Test), after a single oral dose administration in healthy Thai subjects under fasting conditions.
Details
| Lead sponsor | Dr. Reddy's Laboratories (Thailand) Limited |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 48 |
| Start date | 2024-01 |
| Completion | 2024-08 |
Conditions
- Healthy Volunteers
Interventions
- Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg
- Entresto 50 mg
Primary outcomes
- Peak Plasma Concentration (Cmax) — 48 hours
Evaluation of Peak Plasma Concentration (Cmax) - Area under the plasma concentration versus time curve (AUC0-t) — 48 hours
Area under the concentration-time profile to the last quantifiable concentration (AUC0-t) - Area under the plasma concentration versus time curve (AUC0-∞) — 48 hours
Area under the concentration-time profile following administration of a single dose, extrapolated to infinite time (AUC0-∞)
Countries
Thailand