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
01API2024
Quick answer
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 for 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 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. is a Phase 1 program (other) at Pharma Mar S.A. with 1 ClinicalTrials.gov record(s).
Program details
- Company
- Pharma Mar S.A.
- Indication
- 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 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
- Phase
- Phase 1
- Modality
- other
- Status
- active