Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03126695 | A Study to Compare if the Uptake of Ticagrelor in the Body Differs When Different Tablets Are Administered | PHASE1 | COMPLETED | 44 | — | — | May 12, 2017 | Jul 24, 2017 | Aug 2, 2017 | 1 | Germany |
* To determine the relative bioavailability of ticagrelor granule for oral suspension and the pediatric ticagrelor tablet to the commercial ticagrelor tablet in healthy subjects. * To determine the relative bioavailability of ticagrelor pediatric tablet taken whole and the pediatric tablet dispersed in water to the granule for oral suspension in healthy subjects. * To evaluate the bioequivalence between the pediatric ticagrelor tablet taken whole and the pediatric ticagrelor tablet dispersed in water in healthy subjects.
* To determine the relative bioavailability of ticagrelor granule for oral suspension and the pediatric ticagrelor tablet to the commercial ticagrelor tablet in healthy subjects. * To determine the relative bioavailability of ticagrelor pediatric tablet taken whole and the pediatric tablet dispersed in water to the granule for oral suspension in healthy subjects. * To evaluate the bioequivalence between the pediatric ticagrelor tablet taken whole and the pediatric ticagrelor tablet dispersed in water in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 (ADBC) | EXPERIMENTAL | 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 |
| Treatment Sequence 2 (BACD) | EXPERIMENTAL | 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 |
| Treatment Sequence 3 (CBDA) | EXPERIMENTAL | 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 |
| Treatment Sequence 4 (DCAB) | ACTIVE_COMPARATOR | 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 |
| Name | Type | Description |
|---|---|---|
| Ticagrelor granule | DRUG | A P2Y12 receptor inhibitor provided as granule for suspension. |
| Ticagrelor pediatric tablets | DRUG | A P2Y12 receptor inhibitor provided as pediatric tablets to be swallowed whole. |
| Ticagrelor pediatric tablets suspended in water | DRUG | A P2Y12 receptor inhibitor provided as pediatric tablets suspended in water. |
| Ticagrelor immediate release (IR) tablets (Commercial tablet) | DRUG | 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 |
Inclusion Criteria: 1. Provision of signed and dated written informed consent prior to any study specific procedures. 2. Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture. 3. Females must have a negative pregnancy test at Screening and...