CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 51 enrolled
Drug / intervention
Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water +2 moredrug
Likely dose
Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of waterfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02436577
NCT02436577Phase 1Completed
CompareCT.gov

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.

AstraZeneca·interventional·Posted May 7, 2015·Updated Jan 11, 2017

In Brief

A Phase 1 clinical trial evaluating Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water, Ticagrelor OD tablet (90 mg single dose) administered without water, and 1 other intervention for Bioequivalence and 2 related conditions. Completed, enrolled 51 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBioequivalence, Healthy Japanese Subjects, Pharmacokinetics
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 7, 2015
Enrollment StartJun 1, 2015
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.2 years ago

Interventions

Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of waterdrug

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor OD tablet (90 mg single dose) administered without waterdrug

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor IR tablet (90 mg) administered with 150 mL of waterdrug

Ticagrelor 90 mg IR tablet, single dose