Study to assess drug concentrations in plasma of different extended-release formulations of AZD1305
Study identifier:D3190C00016
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Randomised, Open, Single-centre study to Evaluate the Pharmacokinetics of Different Extended-release Formulations of AZD1305 When Given as Single and Repeated Oral Doses to Healthy Male Volunteers
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1305
Sex
Male
Actual Enrollment
24
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Aug 2009
Primary Completion Date: -
Study Completion Date: 01 Nov 2009
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics 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: Part A: 3 way crossover AZD1305: ER test formulation 1 (w/wo food) and reference formulation | Drug: AZD1305 Single Oral Dose, ER formulation 1 |
| Experimental: Part B1: single arm AZD1305: ER test formulation 1 | Drug: AZD1305 ER formulation 1, bid for 5 days |
| Experimental: Part B2: 3 way crossover AZD1305: ER test formulation 2 (w/wo food) and reference formulation | Drug: AZD1305 Single Oral Dose, ER formulation 2 |
Contacts
Investigators
Principal Investigator
Helen Lunde
AstraZeneca R&D Mölndal, Sweden
