A Study to Compare if the Uptake of Ticagrelor in the Body Differs When Different Tablets Are Administered

Phase 1 Completed 44 enrolled AstraZeneca Parexel · collab

RandomizedCrossoverOpen-labelOther

Summary

To evaluate the relative bioavailability of ticagrelor for the different formulations. A randomized cross-over design has been chosen to minimize the effects of between-subject variability and any period effects on the overall results.

Timeline

Start: 2017-05-12
Primary completion: 2017-07-24
Completion: 2017-07-24

Outcome

Met primary endpoint

paper Similar bioavailability of ticagrelor (and AR-C124910XX) was demonstrated for all comparisons tested. PMID 31140114 ↗

Publications

Niazi M, Wissmar J, Berggren AR, Karlsson C, Johanson P. Development Strategy and Relative Bioavailability of a Pediatric Tablet Formulation of Ticagrelor. Clin Drug Investig. 2019 Aug;39(8):765-773. doi: 10.1007/s40261-019-00800-w.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ticagrelor	Small molecule	90 mg	Oral