AZD9056 Relative Bioavailability Study

Study identifier:D1520C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-label, Randomized, 2 cohort, 2 period Crossover Study to Assess the Relative Bioavailability of the Phase III to the Phase IIb Formulation of AZD9056 in Healthy Male and Female Subjects

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD9056 formulation Phase III 50 mg (T), AZD9056 formulation Phase IIb 50 mg (R), AZD9056 formulation Phase III 200 mg (T), AZD9056 formulation Phase IIb 200mg (R)

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 May 2009

Primary Completion Date: -

Study Completion Date: 01 Jul 2009

Study design

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

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Manchester, United Kingdom

Arms	Assigned Interventions
Experimental: 1 50 or 400 mg AZD9056, Test formulation	Drug: AZD9056 formulation Phase III 50 mg (T) Given as 50 mg tablet (T) Drug: AZD9056 formulation Phase III 200 mg (T) Given as 400 mg (2 x 200 mg tablet (T))
Experimental: 2 50 or 400 mg AZD9056, Reference formulation	Drug: AZD9056 formulation Phase IIb 50 mg (R) Given as 50 mg tablet (R) Drug: AZD9056 formulation Phase IIb 200mg (R) Given as 400 mg (2 x 200 mg tablet (R))

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1807&filename=CSR-D1520C00004.pdf
Download
CSR-D1520C00004.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

ICON Development Solutions

(44) 161-232-6525

lucy.williams@iconplc.com

Investigators

Principal Investigator

Mark Layton

AstraZeneca R&D, Alderley Park, UK