Study of an extended release (ER) tablet, single and repeated dosing
Study identifier:D3190C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Two-part, Single-centre, Open (part A) Single blind (part B), Randomised, Placebo-controlled Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics after Single Doses with and without Food and Multiple Ascending Oral Doses of AZD1305 Extended-release Tablet in Healthy & Elderly Subj
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1305, Placebo
Sex
All
Actual Enrollment
94
Study type
Interventional
Age
20 Years - 70 Years
Date
Study Start Date: 01 Apr 2007
Primary Completion Date: 01 Jul 2008
Study Completion Date: 01 Jul 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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: A AZD1305 ER tablet | Drug: AZD1305 ER tablet, administered as single and repeated doses. |
| Placebo Comparator: B Placebo tablet | Drug: Placebo Tablet, administered as single and repeated doses. |
Contacts
Investigators
Principal Investigator
Helen Lunde
AstraZeneca R&D Mölndal, Sweden
