Investigate the safety tolerability and pharmacokinetics of multiple doses of AZD1236
Study identifier:D4260C00006
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomised single centre phase I study to investigate the safety, tolerability and pharmacokinetics of oral multiple ascending daily doses of AZD1236 tablet by a single-blind, placebo-controlled, and single dose relative bioavailability of the oral suspension and oral tablet formulations by an open cross-over in healthy Japanese men
Medical condition
Healthy Volunteer
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1236, Placebo
Sex
Male
Actual Enrollment
48
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Sept 2008
Primary Completion Date: -
Study Completion Date: 01 Dec 2008
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: Active AZD1236 tablet | Drug: AZD1236 75mg once daily or 75mg twice daily will be administered in multiple dose part. |
| Placebo Comparator: Placebo Placebo tablet | Drug: Placebo Placebo tablet matching to the active in multiple dose part. |
| Other: Relative bioavailability AZD1236 Oral suspension | Drug: AZD1236 75mg single dose will be administered in relative bioavailability part. |
| Other: Relative bioavailability tablet AZD1236 tablet | Drug: AZD1236 75mg oral suspension single dose will be administered in relative bioavailability part. |
Contacts
Investigators
Principal Investigator
Shunji Matsuki
Kyushu Clinical Pharmacology Research Clinic
