AZD5672 Bioavailability Study in Healthy Male and Female Subjects
- Registration Number
- NCT00871767
- Lead Sponsor
- AstraZeneca
- Brief Summary
The aim of this study is to compare the blood levels achieved with a new formulation of AZD5672 to an existing formulation of AZD5672 used in previous studies
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Provision of informed consent prior to any study-specific procedures
- BMI between 18 and 30 kg/m2
- Medical and surgical history and physical examination without any clinically significant findings
- Non smokers or past smokers who have stopped smoking within the last 6 months.
Exclusion Criteria
- History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
- Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product.
- Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 AZD5672 40 or 100mg AZD5672, Reference formulation 2 AZD5672 40 or 100mg AZD5672, Test formulation
- Primary Outcome Measures
Name Time Method Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28
- Secondary Outcome Measures
Name Time Method Safety variables (adverse events, blood pressure, pulse, safety lab) AE assessed throughout whole the study, twice weekly assessment of BP, pulse and safety labs throughout study period
Trial Locations
- Locations (1)
Research Site
🇬🇧Manchester, United Kingdom