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
16
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
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Sylvan Hurewitz
AstraZeneca Clinical Pharmacology Unit, US
