A randomized, open-label, single dose, 2-way crossover bioequivalence study comparing apixaban 5 mg hard capsules (PG412 [Celon Pharma]) vs apixaban 5 mg film-coated tablets (Eliquis [Bristol-Myers Squibb]) under fasting conditions in healthy volunteers
Phase 1
- Conditions
- Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA)age= 75 yearshypertensiondiabetes mellitussymptomatic heart failure (NYHA Class = II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.MedDRA version: 21.1Level: PTClassification code: 10051055Term: Deep vein thrombosis Class: 100000004866MedDRA version: 23.1Level: LLTClassification code: 10084868Term: Systemic embolism Class: 100000004848MedDRA version: 20.0Level: LLTClassification code: 10014521Term: Embolism pulmonary Class: 10038738Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-511526-31-00
- Lead Sponsor
- Celon Pharma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 38
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
- Secondary Outcome Measures
Name Time Method