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
24
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
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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)) |
Contacts
Investigators
Principal Investigator
Mark Layton
AstraZeneca R&D, Alderley Park, UK
