Study identifier:D5136C00011
ClinicalTrials.gov identifier:NCT03126695
EudraCT identifier:N/A
CTIS identifier:N/A
An Open-label, Randomized, 4-period, 4-treatment, Cross-over, Single-center, Single-dose Study to Assess the Relative Bioavailability of Ticagrelor in Different Formulations in Healthy Adult Subjects
Sickle cell disease
Phase 1
Yes
Ticagrelor granule, Ticagrelor pediatric tablets, Ticagrelor pediatric tablets suspended in water, Ticagrelor immediate release (IR) tablets (Commercial tablet)
All
44
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verified 01 Jun 2018 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Treatment Sequence 1 (ADBC) Subjects were randomized to treatment sequence ADBC: On Day 1, following an overnight fast of at least 10 hours, each subject will receive single dose of the treatment assigned to that treatment period. A =Ticagrelor granule for oral suspension equal to 90 mg. B = Ticagrelor pediatric tablets equal to 90 mg. C= Ticagrelor pediatric tablets suspended in water equal to 90 mg. D = Ticagrelor commercial IR (1 x 90 mg) tablet | Drug: Ticagrelor granule A P2Y12 receptor inhibitor provided as granule for suspension. Drug: Ticagrelor pediatric tablets A P2Y12 receptor inhibitor provided as pediatric tablets to be swallowed whole. Drug: Ticagrelor pediatric tablets suspended in water A P2Y12 receptor inhibitor provided as pediatric tablets suspended in water. Drug: Ticagrelor immediate release (IR) tablets (Commercial tablet) A P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (unstable angina, non-ST (S and T waves) elevation MI or ST elevation MI) and in patients with a history of MI Other Name: Brilinta |
Experimental: Treatment Sequence 2 (BACD) Subjects were randomized to treatment sequence BACD: On Day 1, following an overnight fast of at least 10 hours, each subjects will receive single dose of the treatment assigned to that treatment period. A =Ticagrelor granule for oral suspension equal to 90 mg. B = Ticagrelor pediatric tablets equal to 90 mg. C= Ticagrelor pediatric tablets suspended in water equal to 90 mg. D = Ticagrelor commercial IR (1 x 90 mg) tablet | Drug: Ticagrelor granule A P2Y12 receptor inhibitor provided as granule for suspension. Drug: Ticagrelor pediatric tablets A P2Y12 receptor inhibitor provided as pediatric tablets to be swallowed whole. Drug: Ticagrelor pediatric tablets suspended in water A P2Y12 receptor inhibitor provided as pediatric tablets suspended in water. Drug: Ticagrelor immediate release (IR) tablets (Commercial tablet) A P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (unstable angina, non-ST (S and T waves) elevation MI or ST elevation MI) and in patients with a history of MI Other Name: Brilinta |
Experimental: Treatment Sequence 3 (CBDA) Subjects were randomized to treatment sequence CBDA: On Day 1, following an overnight fast of at least 10 hours, each subjects will receive single dose of the treatment assigned to that treatment period. A =Ticagrelor granule for oral suspension equal to 90 mg. B = Ticagrelor pediatric tablets equal to 90 mg. C= Ticagrelor pediatric tablets suspended in water equal to 90 mg. D = Ticagrelor commercial IR (1 x 90 mg) tablet | Drug: Ticagrelor granule A P2Y12 receptor inhibitor provided as granule for suspension. Drug: Ticagrelor pediatric tablets A P2Y12 receptor inhibitor provided as pediatric tablets to be swallowed whole. Drug: Ticagrelor pediatric tablets suspended in water A P2Y12 receptor inhibitor provided as pediatric tablets suspended in water. Drug: Ticagrelor immediate release (IR) tablets (Commercial tablet) A P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (unstable angina, non-ST (S and T waves) elevation MI or ST elevation MI) and in patients with a history of MI Other Name: Brilinta |
Active Comparator: Treatment Sequence 4 (DCAB) Subjects were randomized to treatment sequence DCAB: On Day 1, following an overnight fast of at least 10 hours, each subjects will receive single dose of the treatment assigned to that treatment period. A =Ticagrelor granule for oral suspension equal to 90 mg. B = Ticagrelor pediatric tablets equal to 90 mg. C= Ticagrelor pediatric tablets suspended in water equal to 90 mg. D = Ticagrelor commercial IR (1 x 90 mg) tablet | Drug: Ticagrelor granule A P2Y12 receptor inhibitor provided as granule for suspension. Drug: Ticagrelor pediatric tablets A P2Y12 receptor inhibitor provided as pediatric tablets to be swallowed whole. Drug: Ticagrelor pediatric tablets suspended in water A P2Y12 receptor inhibitor provided as pediatric tablets suspended in water. Drug: Ticagrelor immediate release (IR) tablets (Commercial tablet) A P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (unstable angina, non-ST (S and T waves) elevation MI or ST elevation MI) and in patients with a history of MI Other Name: Brilinta |