Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

AZD3480 + Aripiprazole

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

AZD3480 capsules qd, oral, 22 days

Aripiprazole

Intervention Type DRUG

single dose on day 5

2

Placebo + Aripiprazole

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo qd, 12 days

Aripiprazole

Intervention Type DRUG

single dose on day 5

Interventions

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AZD3480

AZD3480 capsules qd, oral, 22 days

Intervention Type DRUG

Placebo

Placebo qd, 12 days

Intervention Type DRUG

Aripiprazole

single dose on day 5

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes