A pivotal, randomized, open-label, two-treatment, two-sequence, four periods, crossover clinical trial to evaluate the bioequivalence of single doses of Test product Sacubitril/Valsartan, film-coated tablets 97 mg/103 mg (Manufacturer: JSC «Farmak», Ukraine) and Reference Entresto®, film-coated tablets 97 mg/103 mg (Novartis Europharm Limited, Ireland) in healthy subjects under fasted conditions
Phase 1
Recruiting
- Conditions
- HealthyTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-509484-24-00
- Lead Sponsor
- Farmak JSC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method