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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug Drug Interaction

Intervention: Ticagrelor (Drug); Venlaflaxin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Jay Horrow, PhD, Study Director, Affiliation: AstraZeneca Wilmington
Mirjana Kujacic, PhD, Study Chair, Affiliation: AstraZeneca Mölndal
Kelli Craven, MD, Principal Investigator, Affiliation: Quintiles Kansas Overland Park US

Summary

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

Clinical Details

Official title: A Sequential, Open Label Study to Compare the Pharmacokinetics, Safety and Tolerability of Ticagrelor and Venlafaxine Given Concomitantly in Healthy Subjects Aged 18 to 45 Years

Study design: Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: area under the plasma concentration-time curve during a dosing interval (AUCτ) and observed maximum plasma concentration (Cmax)

Secondary outcome:

Venlafaxine and ODV on Days 8 and 9: time to Cmax (tmax)

Safety and tolerability of ticagrelor and venlafaxine when given concomitantly by assessments of amount of adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, Uppsala, Sweden

Research Site, Overland Park, Kansas, United States

Additional Information

Starting date: May 2011
Last updated: March 29, 2012

Page last updated: August 23, 2015

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