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Evaluation of the Drug-drug Interaction Between Ticagrelor and Venlafaxine When Taken Together in Healthy Volunteers

NCT ID: NCT01350921

Last Updated: 2012-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-03-31

Brief Summary

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Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken together in healthy volunteers

Detailed Description

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Conditions

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Drug Drug Interaction

Keywords

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phase 1 ticagrelor venlafaxine

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Ticagrelor

90 mg oral immediate release tablets, single dose on days 1 and 9

Intervention Type DRUG

Venlaflaxin

37.5 mg oral immediate release tablets, administered twice daily on days 4-8

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* a weight of at least 50 kg and a body mass index between 18 to 30 kg/m2

Exclusion Criteria

* History of clinically significant disease or disorder as judged by the investigator
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug.
* History of haemophilia, von Willebrand´s disease, lupus anticoagulant or other diseases/syndromes that may alter or increase bleeding.
* History of previous or ongoing psychiatric disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jay Horrow, PhD

Role: STUDY_DIRECTOR

AstraZeneca Wilmington

Mirjana Kujacic, PhD

Role: STUDY_CHAIR

AstraZeneca Mölndal

Kelli Craven, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles Kansas Overland Park US

Locations

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Research Site

Overland Park, Kansas, United States

Site Status

Research Site

Uppsala, , Sweden

Site Status

Countries

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United States Sweden

Other Identifiers

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D5130C00073

Identifier Type: -

Identifier Source: org_study_id