Conditions: Sickle Cell Disease
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 18
Healthy volunteers: yes

Brief summary:
This study compares the clinical tablet formulation of prasugrel taken orally with an orally disintegrating tablet (ODT) taken orally. The study will evaluate the amount of prasugrel active metabolite circulating in the blood for each treatment.

Detailed description:

Arms:
arm 1: A single 5-milligram (mg) prasugrel tablet administered orally by swallowing it whole on 1 occasion. arm 2: A single 5-mg prasugrel orally disintegrating tablet (ODT) administered orally by placing it on top of the tongue and keeping it there until it disintegrates. arm 3: A single 5-mg prasugrel ODT administered orally by placing it on top of the tongue followed by drinking approximately 180 milliliters (ml) apple juice within 1 minute after the tablet finishes disintegration. arm 4: A single 5-mg prasugrel ODT administered orally by placing it on top of the tongue, but then chewed and swallowed rather than waiting for it to disintegrate. arm 5: A single 5-mg prasugrel ODT administered orally by placing it under (rather than on top of) the tongue and keeping it there until it disintegrates.

Interventions: intervention 1: Prasugrel (clinical formulation) intervention 2: Prasugrel (Orally Disintegrating Tablet [ODT])
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol document: