NCT02436577

Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Japanese Subjects

An Open-label, Randomized, Three-period, Three-treatment, Crossover, Single-centre, Single-dose Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Healthy Japanese Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Study to evaluate the bioequivalence of ticagrelor orodispersible (OD) tablets administered with water and without water and ticagrelor immediate-release (IR) tablets.

Conditions

• Bioequivalence
• Healthy Japanese Subjects
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water	Ticagrelor 90 mg OD tablet, single dose
DRUG	Ticagrelor OD tablet (90 mg single dose) administered without water	Ticagrelor 90 mg OD tablet, single dose
DRUG	Ticagrelor IR tablet (90 mg) administered with 150 mL of water	Ticagrelor 90 mg IR tablet, single dose

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-05-07
• Last updated: 2017-01-11
• Results posted: 2017-01-11

Locations

1 site across 1 country: United Kingdom