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

NCT02436577 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-01-11

Study results available
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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.

Conditions

  • Bioequivalence
  • Healthy Japanese Subjects
  • Pharmacokinetics

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Annelize Koch, Dr. · PAREXEL Early Phase Clinical Unit London

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02436577 on ClinicalTrials.gov