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Phase I 2-Way Crossover Study to Assess Relative BA of Tablet Versus Liquid Suspension and Food Effect on Tablet Formulation

NCT ID: NCT00867685

Last Updated: 2009-04-30

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this study is to compare the liquid suspension form of AZD 2624 to a tablet form of the same drug. This study will also study the effect of food on the tablet form of the drug.

Detailed Description

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Conditions

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Healthy

Keywords

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A

Single oral dose of 40 mg AZD2624 liquid suspension in a fasted state.

Group Type EXPERIMENTAL

AZD2624

Intervention Type DRUG

Single dose of 40 mg AZD2624 liquid suspension, PO

Treatment B

Single oral dose of 40 mg (2x20mg tablets)AZD2624 in a fasted state.

Group Type EXPERIMENTAL

AZD2624

Intervention Type DRUG

Single dose of 40 mg AZD 2624 (2x20mg tablets), PO

Treatment C

Single oral dose of 40 mg (2x20mg tablets) in a fed state.

Group Type EXPERIMENTAL

AZD2624

Intervention Type DRUG

Single dose of 40 mg AZD 2624 (2x20mg tablets), PO

Interventions

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AZD2624

Single dose of 40 mg AZD2624 liquid suspension, PO

Intervention Type DRUG

AZD2624

Single dose of 40 mg AZD 2624 (2x20mg tablets), PO

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female volunteers

Exclusion Criteria

* Donation of plasma or blood products within one month of of screening
* Clinically relevant abnormalities in physical examination, vital signs,ECG, clinical chemistry, hematology, or urinalysis.
* Previous participation in an AD2624 study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Sylvan Hurewitz, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca Clinical Pharmacology Unit, US

Locations

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Research Site

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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D0970C00008

Identifier Type: -

Identifier Source: org_study_id