A Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 after oral Single and Repeated Doses
Study identifier:D1950C00013
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 in Young and Elderly Healthy Japanese volunteers after oral Single and Repeated Doses
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1446, Placebo
Sex
All
Actual Enrollment
24
Study type
Interventional
Age
20 Years - 80 Years
Date
Study Start Date: 01 Sept 2010
Primary Completion Date: 01 Dec 2010
Study Completion Date: 01 Dec 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Oral capsule. Dose single and followed by 5-day repeated dosing. Specific doses depend on panel. | Drug: AZD1446 oral capsule, Moderate Release |
| Placebo Comparator: 2 Oral capsule. Dose single and followed by 5-day repeated dosing. | Drug: Placebo oral capsule Other Name: Placebo |
Contacts
Investigators
Principal Investigator
Björn Paulsson
AstraZeneca R&D Södertälje
