Conditions: Bioequivalence Healthy Japanese Subjects Pharmacokinetics
Keywords: ticagrelor orodispersible tablet ticagrelor immediate-release tablet bioequivalence Phase I healthy Japanese subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 51
Healthy volunteers: yes

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

The objective of the study is to assess the bioequivalence of ticagrelor orodispersible (OD) tablets when administered with water and without water and ticagrelor immediate-release (IR) tablets.

Detailed description:
Study to evaluate the bioequivalence of ticagrelor orodispersible (OD) tablets administered with water and without water and ticagrelor immediate-release (IR) tablets.

Arms:
arm 1: Treatment A in Period 1, Treatment B in Period 2 and Treatment C in Period 3 arm 2: Treatment B in Period 1, Treatment C in Period 2 and Treatment A in Period 3 arm 3: Treatment C in Period 1, Treatment A in Period 2 and Treatment B in Period 3 arm 4: Treatment A in Period 1, Treatment C in Period 2 and Treatment B in Period 3 arm 5: Treatment B in Period 1, Treatment A in Period 2 and Treatment C in Period 3 arm 6: Treatment C in Period 1, Treatment B in Period 2 and Treatment A in Period 3

Interventions: intervention 1: Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water intervention 2: Ticagrelor OD tablet (90 mg single dose) administered without water intervention 3: Ticagrelor IR tablet (90 mg) administered with 150 mL of water
Intervention descriptions: intervention 1: Ticagrelor 90 mg OD tablet, single dose intervention 2: Ticagrelor 90 mg OD tablet, single dose intervention 3: Ticagrelor 90 mg IR tablet, single dose

Protocol document: