AZD2066 Cocktail Study
Study identifier:D0475C00011
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open label, Multi Centre Study in Healthy Volunteers to Estimate the Effect of Multiple Doses of AZD2066 on the Activity of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 by Administering a Cocktail of Caffeine, Bupropion, Tolbutamide, Omeprazole, Metoprolol and Midazolam
Medical condition
Chronic Pain
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD2066, Caffeine, Tolbutamide, Omeprazole Tablet, 20 mg, Midazolam Tablet, 7.5 mg
Sex
All
Actual Enrollment
15
Study type
Interventional
Age
18 Years - 60 Years
Date
Study Start Date: 01 Jun 2009
Primary Completion Date: -
Study Completion Date: 01 Sept 2009
Study design
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group 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 12 AZD2066 Capsule, 2 mg & 8 mg 2 Caffeine Tablet, 2 x 50 mg 2 Tolbutamide Tablet, half of 500 mg 2 Omeprazole Tablet, 20 mg 2 Midazolam Tablet, 7.5 mg 2 Metoprolol Tablet, 100 mg 2 Bupropion Tablet, 150 mg | Drug: AZD2066 12 doses, Given as capsule, 2 mg & 8 mg Drug: Caffeine 2 doses, Given as Tablet, 2x50 mg Other Name: Pharmapac/ProPlus® Drug: Tolbutamide 2 doses, Given as Tablet, half of 500 mg Other Name: Actavis /generic Drug: Omeprazole Tablet, 20 mg 2 doses, Given as Tablet, 20 mg Other Name: AstraZeneca/Losec® MUPS® Drug: Midazolam Tablet, 7.5 mg 2 doses, Given as Tablet, 7.5 mg Other Name: Roche/generic |
Contacts
Investigators
Principal Investigator
Biljana Lilja
AstraZeneca R&D, Södertälje, Sweden
