Conditions: Bioavailability Healthy Subjects
Keywords: ticagrelor orodispersible tablet ticagrelor immediate-release tablet relative bioavailability Phase I healthy subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 100
Healthy volunteers: yes

Brief summary:
This study will be an open-label, randomised, four-period, four-treatment, crossover study in healthy male and female of non-childbearing potential subjects, performed at a single study centre.

The objective of the study is to assess the bioavailability of ticagrelor orodispersible (OD) tablets when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor immediate-release (IR) tablets

Detailed description:
Study to evaluate the bioavailability of ticagrelor OD tablets administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.

Arms:
arm 1: Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4 arm 2: Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4 arm 3: Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4 arm 4: Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4

Interventions: intervention 1: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water intervention 2: Ticagrelor OD tablet (90 mg single dose) administered without water intervention 3: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube intervention 4: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water
Intervention descriptions: intervention 1: 90 mg single dose intervention 2: 90 mg single dose intervention 3: 90 mg single dose intervention 4: 90 mg single dose

Protocol document: