NCT00871767CompletedPhase 1
An Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Experimental
40 or 100mg AZD5672, Reference formulation
Intervention: AZD5672 (Drug)
2
Experimental
40 or 100mg AZD5672, Test formulation
Intervention: AZD5672 (Drug)
Outcomes
Primary Outcomes
Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss
Time Frame: Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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