Conditions: Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: yes

Brief summary:
The purpose of this study is to evaluate the amount of drug available in the body when given to healthy participants as two different formulations with or without a meal. In addition, this study will evaluate how much of the drug gets into the blood stream and how long the body takes to get rid of it. Information about any side effects that may occur will also be collected. Each participant will receive a total of five different treatments. Each treatment is given by mouth, once a day. The treatment period lasts for five consecutive days.

Detailed description:
The reference formulation is an orally disintegrating tablet without Magnasweet® (ODT1) and the test formulation is an orally disintegrating tablet containing Magnasweet® (ODT2).

Arms:
arm 1: 5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state. arm 2: 5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state. arm 3: 5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state. arm 4: 5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast. arm 5: 2 mg Prasugrel as ODT2 formulation administered once in the fasted state.

Interventions: intervention 1: Prasugrel ODT1 - Tablet intervention 2: Prasugrel ODT2 - Tablet intervention 3: Prasugrel ODT2 - Suspension
Intervention descriptions: intervention 1: Administered orally as tablet. intervention 2: Administered orally as tablet. intervention 3: Administered orally as suspension.

Protocol document: