drugset / Trial / NCT06248112
Sacubitril 97 mg and Valsartan 103 mg Film-coated Tablets Relative to Entresto 97 mg/103 mg Film-coated Tablets
Non-randomizedCrossoverOpen-labelBasic science
Summary
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be a randomized, open-label, single oral dose, full replicated crossover design with four-period, two-treatment, and two-sequence under fasting condition and at least 14 days washout period between the doses.
Timeline
- Start
- 2024-05-06
- Primary completion
- 2024-06-22
- Completion
- 2024-07-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sacubitril | Small molecule | 97 mg | Oral |
| Subject | Valsartan | Small molecule | 103 mg | Oral |
Indications
No indication recorded.