Evaluate different extended-release (ER) tablets/capsules of AZD1305 - 2007-005765-38
Study identifier:D3190C00014
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A phase I, two-part, randomised, open, single-centre, crossover study to evaluate different extended-release formulations of AZD1305 when given as single oral doses to healthy male volunteers
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1305
Sex
Male
Actual Enrollment
50
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Feb 2008
Primary Completion Date: 01 Jul 2008
Study Completion Date: 01 Jul 2008
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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: 2x2 crossover 4 different AZD1305 ER formulations | Drug: AZD1305 Extended release capsules, oral single doses |
| Experimental: Part B: 3x3 crossover 2 different AZD1305 ER formulations and a reference formulation | Drug: AZD1305 Extended release capsules, oral single doses |
Contacts
Investigators
Principal Investigator
Helen Lunde
AstraZeneca R&D Mölndal, Sweden
