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Study to Assess the Bioavailability of Ticagrelor OD Tablet vs. IR Tablet

NCT02400333 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-09-29

Study results available
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Summary

This study will be an open-label, randomised, four-period, four-treatment, crossover study in healthy male and female of non-childbearing potential subjects, performed at a single study centre.

The objective of the study is to assess the bioavailability of ticagrelor orodispersible (OD) tablets when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor immediate-release (IR) tablets

Conditions

  • Bioavailability
  • Healthy Subjects

Interventions

DRUG

Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water

90 mg single dose

DRUG

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

90 mg single dose

DRUG

Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube

90 mg single dose

DRUG

Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water

90 mg single dose

Sponsors & Collaborators

Principal Investigators

  • Rainard Fuhr, Dr. med. · PAREXEL International GmbH, Berlin

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Germany

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 NCT02400333 on ClinicalTrials.gov