NCT02400333

Study to Assess the Bioavailability of Ticagrelor OD Tablet vs. IR Tablet

An Open-label, Randomised, Four-period, Four-treatment, Crossover, Single-centre, Single-dose Study to Assess the Bioavailability of Ticagrelor Orodispersible Tablets, Compared to Ticagrelor Immediate-release Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will be an open-label, randomised, four-period, four-treatment, crossover study in healthy male and female of non-childbearing potential subjects, performed at a single study centre. The objective of the study is to assess the bioavailability of ticagrelor orodispersible (OD) tablets when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor immediate-release (IR) tablets

Detailed description

Study to evaluate the bioavailability of ticagrelor OD tablets administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.

Conditions

• Bioavailability
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water	90 mg single dose
DRUG	Ticagrelor OD tablet (90 mg single dose) administered without water	90 mg single dose
DRUG	Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube	90 mg single dose
DRUG	Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water	90 mg single dose

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-03-27
• Last updated: 2016-09-29
• Results posted: 2016-08-03

Locations

1 site across 1 country: Germany