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AZD 2066 Single Dose Formulation and Food Effect Study in Healthy Volunteers

NCT ID: NCT00690404

Last Updated: 2010-12-10

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-06-30

Brief Summary

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A open label two way crossover formulation and food effect study in healthy volunteers to assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an oral solution

Detailed Description

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Conditions

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Healthy

Keywords

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formulation pharmacokinetic crossover formulation food effect oral solution healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

AZD2066

Intervention Type DRUG

single oral dose

Interventions

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AZD2066

single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical normal physical findings, including BP, pulse rate \>45 bpm, ECG and laboratory assessments
* Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg

Exclusion Criteria

* History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.
Minimum Eligible Age

20 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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AstraZeneca Pharmaceuticals

Principal Investigators

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Eleanor Lisbon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc. Overland Park, Kansas, USA

Heather Wray, MB, ChB, FFPM

Role: STUDY_CHAIR

AstraZeneca Charnwood England

Ivan Eggens, MD

Role: STUDY_CHAIR

AstraZeneca , Södertälje, Sweden

Other Identifiers

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D0475C00005

Identifier Type: -

Identifier Source: org_study_id