Phase I 2-way crossover study to assess relative BA of tablet versus liquid suspension and food effect on tablet formulation

Study identifier:D0970C00008

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, randomized, open label, 2-way crossover study in healthy subjects to assess the relative bioavailability of AZD2624 (tablet versus liquid suspension) followed by an additional period to assess the food effect on the tablet

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD2624

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Mar 2009

Primary Completion Date: -

Study Completion Date: 01 Apr 2009

Study design

Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Philadelphia, PA, United States

Arms	Assigned Interventions
Experimental: Treatment A Single oral dose of 40 mg AZD2624 liquid suspension in a fasted state.	Drug: AZD2624 Single dose of 40 mg AZD2624 liquid suspension, PO
Experimental: Treatment B Single oral dose of 40 mg (2x20mg tablets)AZD2624 in a fasted state.	Drug: AZD2624 Single dose of 40 mg AZD 2624 (2x20mg tablets), PO
Experimental: Treatment C Single oral dose of 40 mg (2x20mg tablets) in a fed state.	Drug: AZD2624 Single dose of 40 mg AZD 2624 (2x20mg tablets), PO

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1689&filename=CSR-D0970C00008.pdf
Download
CSR-D0970C00008.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Sylvan Hurewitz

AstraZeneca Clinical Pharmacology Unit, US