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Completed

NCT Number: NCT00689637

Drug Interaction Study Between AZD3480 and Warfarin

The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research SIte

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed written informed consent
  • Clinically normal physical findings and laboratory values

Exclusion criteria

  • Clinically significant illness or clinically relevant trauma within three weeks before the first dose
  • History of clinically significant disease
  • Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Treatment and study plan

AZD3480

Drug

AZD3480 capsules qd, 12 days

Placebo

Drug

Placebo capsules qd, 12 days

Warfarin

Drug

Warfarin: single dose on day 6

Primary outcomes

  1. PK variables

    Time frame: Frequent sampling occasions during days 5 and 6

Secondary outcomes

  1. Safety variables (adverse events, blood pressure, pulse, safety lab)

    Time frame: During the whole treatment period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Single-Centre, Double Blind, Randomized, Two-Way Cross-Over Study of Repeated Doses of AZD3480 and Single Dose of Warfarin to Evaluate the Pharmacokinetic Interaction of AZD3480 and Warfarin and the Effect of AZD3480 Pharmacodynamic in Healthy Male Subjects (Phase I

Acronym: DDI

Important dates

Study start
2007
Study completion
2009
First posted
Jun 3, 2008
Registry last updated
Jul 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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