A bioequivalency study of ticagrelor in healthy Japanese subjects
Research type
Research Study
Full title
An open-label, randomized three-period, three-treatment crossover single-center, single-dose study to assess the bioequivalence between ticagrelor orodipersible tablets and ticagrelor immediate release tablets in healthy Japanese subjects.
IRAS ID
177596
Contact name
Annelize Koch
Contact email
Sponsor organisation
AstraZeneca Pharmaceuticals
Eudract number
2015-001045-91
Duration of Study in the UK
0 years, 2 months, 11 days
Research summary
The new medicine tested in this study is a new formulation of a substance called ticagrelor. The sponsor (AstraZeneca) is developing the study drug to be used to prevent blood clotting that can cause strokes and heart attacks.
This study will compare the orodispersible (OD) formulation (a type of tablet that dissolves in the mouth just with saliva – no water should be needed to take the tablet) of the study drug when given with and without water to the immediate release (IR) tablet formulation of the study drug that is already on the market, namely Brilinta®.
The main purpose of the study is to compare the study drug (ticagrelor) with the comparator drug (Brilinta®) to determine if they are similar in regards to how they are taken up, metabolised (chemically broken down), distributed through the body and excreted. A further aim of the study is to see how safe the study drug is and how well it is tolerated after dosing.
This study will recruit healthy, non-smoking, Japanese males and females (of non-childbearing potential) between the ages of 20 and 45 years (inclusive). A total of 42 subjects will take part in the study.
The total study duration for each subject will be approximately 7 to 8 weeks.
Blood samples for pharmacokinetic analysis will be collected. Vital signs, electrocardiogram measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
15/EE/0102
Date of REC Opinion
14 Apr 2015
REC opinion
Favourable Opinion