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

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

GÖTEBORG, Sweden

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.

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1322&filename=CSR-D3190C00004.pdf
Download
CSR-D3190C00004.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Helen Lunde

AstraZeneca R&D Mölndal, Sweden