Study of an Extended Release (ER) Tablet, Single and Repeated Dosing
The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how the medication is metabolised by the body (how it is taken up, distributed, and how it disappears from the body). The study is performed in healthy volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|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|
- Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight [ Time Frame: During the study ] [ Designated as safety issue: Yes ]
- Pharmacokinetic variables [ Time Frame: During all dosing visits ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
AZD1305 ER tablet
ER tablet, administered as single and repeated doses.
Placebo Comparator: B
Tablet, administered as single and repeated doses.
|Study Director:||Helen Lunde, MD||AstraZeneca R&D Mölndal, Sweden|
|Principal Investigator:||Marianne Hartford, MD, PhD||AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden|