Conditions: Anticoagulation
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 43
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess the effect of two 4-Factor PCC formulations on Apixaban pharmacodynamics in healthy adult subjects.

Detailed description:

Arms:
arm 1: Apixaban 10 mg Tablet orally \[Day 1-Day 3: twice daily (BID), Day 4: Single Dose (SD)\] followed 3hr later by Saline solution (placebo) 0 IU/kg infusion for 30 min Intravenously arm 2: Apixaban 10 mg Tablet orally \[Day 1-Day 3: twice daily (BID), Day 4: Single Dose (SD)\] followed 3hr later by a Cofact (4-Factor PCC) 50 IU/kg infusion for 30 min Intravenously arm 3: Apixaban 10 mg Tablet orally \[Day 1-Day 3: twice daily (BID), Day 4: Single Dose (SD)\] followed 3hr later by a Beriplex P/N (4-Factor PCC) 50 IU/kg infusion for 30 min Intravenously

Interventions: intervention 1: Apixaban intervention 2: Cofact (4-Factor PCC) intervention 3: Beriplex P/N (4-Factor PCC) intervention 4: Placebo (Saline solution)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: