Relative Bioavailability of Phase II and Phase III Formulations of AZD0530
- Registration Number
- NCT00771979
- Lead Sponsor
- AstraZeneca
- Brief Summary
The aim of the study is to compare how different formulations of AZD0530 are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Female subjects must be of Non- child-bearing potential
- Body mass index between 19 and 30 kg/m2 and weigh between 50-100 kg
Exclusion Criteria
- Presence of any clinically significant illness
- Abnormal vital signs
- History of any conditions that may put the subject at risk by participating in the study
- Participation in another clinical study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 AZD0530 -
- Primary Outcome Measures
Name Time Method To compare the pharmacokinetic parameters for AZD0530 when administered as Phase III formulation in relation to Phase II formulation. Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples.
- Secondary Outcome Measures
Name Time Method To monitor the safety of all subjects by assessment of vital signs, ECG, clinical chemistry, haematology, urinalysis and adverse events. From time of consent to last visit. An exploratory objective is to characterise the Pharmacokinetic profile of an oral solution of AZD0530 and 4 additional tablet variants of the Phase III formulation of AZD0530 Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples.
Trial Locations
- Locations (1)
Research Site
🇬🇧Alderley Park, United Kingdom