AZD0837 Extended Release (ER) Japan Study - ER J ph I
Study identifier:D1250C00055
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A single-blind, randomised, placebo-controlled, parallel-group, single centre phase I study to assess the safety, tolerability and pharmacokinetics of extended-release tablets AZD0837 after single and repeated oral administration to young healthy male Japanese subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD0837, Placebo
Sex
Male
Actual Enrollment
36
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 May 2009
Primary Completion Date: -
Study Completion Date: 01 Jun 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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: 1 Low dose | Drug: AZD0837 tablet, oral, once daily, 1+5 days |
| Experimental: 2 Middle dose | Drug: AZD0837 tablet, oral, once daily, 1+5 days |
| Experimental: 3 High dose | Drug: AZD0837 tablet, oral, once daily, 1+5 days |
| Placebo Comparator: 4 placebo | Drug: Placebo Placebo |
Contacts
Investigators
Principal Investigator
Hiroyuki Fukase
CPC Clinic, Medipolis Medical Research Institute, Kagoshima, Japan
