Phase I 2-Way Crossover Study to Assess Relative BA of Tablet Versus Liquid Suspension and Food Effect on Tablet Formulation
- Registration Number
- NCT00867685
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to compare the liquid suspension form of AZD 2624 to a tablet form of the same drug. This study will also study the effect of food on the tablet form of the drug.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Healthy male and female volunteers
Exclusion Criteria
- Donation of plasma or blood products within one month of of screening
- Clinically relevant abnormalities in physical examination, vital signs,ECG, clinical chemistry, hematology, or urinalysis.
- Previous participation in an AD2624 study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A AZD2624 Single oral dose of 40 mg AZD2624 liquid suspension in a fasted state. Treatment B AZD2624 Single oral dose of 40 mg (2x20mg tablets)AZD2624 in a fasted state. Treatment C AZD2624 Single oral dose of 40 mg (2x20mg tablets) in a fed state.
- Primary Outcome Measures
Name Time Method Serial blood draws will be used to measure the plasma levels of AZD2624 for the liquid suspension and the tablet formulation in a fed and fasted state. Seventeen blood draws will be collected during each treatment period for a total of 51 samples for the study.
- Secondary Outcome Measures
Name Time Method Safety will be measured by the collection of AEs, ECGs, physical exams, and vital signs. Subjects inquiry on AE daily, ECGs collected at 2 timepoints each period, clinical labs collected at 3 timepoints each period, physical exams completed 3 timepoints each period, and vital signs collected each day of each period
Trial Locations
- Locations (1)
Research Site
🇺🇸Philadelphia, Pennsylvania, United States