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A Study to Compare if the Uptake of Ticagrelor in the Body Differs When Different Tablets Are Administered

NCT03126695 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-08-02

No results posted yet for this study

Summary

To evaluate the relative bioavailability of ticagrelor for the different formulations. A randomized cross-over design has been chosen to minimize the effects of between-subject variability and any period effects on the overall results.

Conditions

Interventions

DRUG

Ticagrelor granule

A P2Y12 receptor inhibitor provided as granule for suspension.

DRUG

Ticagrelor pediatric tablets

A P2Y12 receptor inhibitor provided as pediatric tablets to be swallowed whole.

DRUG

Ticagrelor pediatric tablets suspended in water

A P2Y12 receptor inhibitor provided as pediatric tablets suspended in water.

DRUG

Ticagrelor immediate release (IR) tablets (Commercial tablet)

A P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (unstable angina, non-ST (S and T waves) elevation MI or ST elevation MI) and in patients with a history of MI

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Rainard Fuhr, Dr. med. · PAREXEL Early Phase Clinical Unit Berlin

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-12
Primary Completion
2017-07-24
Completion
2017-07-24

Countries

  • Germany

Study Locations

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Entities

Diseases
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 NCT03126695 on ClinicalTrials.gov