Conditions: Hematology
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 117
Healthy volunteers: yes

Brief summary:
To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory effect of a low dose Immediate Release Aspirin (IR ASA) regimen.

Detailed description:

Arms:
arm 1: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. arm 2: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. arm 3: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. arm 4: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed. arm 5: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. arm 6: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.

Interventions: intervention 1: Naproxen Sodium (Aleve, BAY117031) intervention 2: Acetylsalicylic Acid (Aspirin, BAYE4465)
Intervention descriptions: intervention 1: Naproxen sodium 220 mg qd or bid intervention 2: ASA 81 mg qd

Protocol document: