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 granule, Ticagrelor granule, Ticagrelor granule, Ticagrelor pediatric tablets, Ticagrelor pediatric tablets, Ticagrelor pediatric tablets, Ticagrelor pediatric tablets, Ticagrelor pediatric tablets suspended in water, Ticagrelor pediatric tablets suspended in water, Ticagrelor pediatric tablets suspended in water, Ticagrelor pediatric tablets suspended in water, Ticagrelor immediate release (IR) tablets (Commercial tablet), Ticagrelor immediate release (IR) tablets (Commercial tablet), Ticagrelor immediate release (IR) tablets (Commercial tablet), 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 |