Coronary Artery Disease (CAD) Clinical Trial
Official title:
A Randomized, Single-dose, Open-label, Single-center, Crossover Study to Assess the Relative Bioavailability and Safety of Different Formulations of AZD5718 in Healthy Volunteers
The study is a randomized, single-dose, open-label, combined 2x2 dose and 3x3 dose crossover design in fixed sequence. In this study, the relative bioavailability of different formulations of AZD5718 will be assessed in healthy volunteers in order to compare the exposure of Formulations A to D to the AZD5718 film-coated tablet formulation. The overall treatment period will start with a 2-period, 2-dose treatment crossover, followed by a 3-period, 3-dose treatment crossover.
This study will be conducted at a single study center in Parexel Early Phase Clinical Unit
London.
A total of 12 healthy male and female volunteers (of non-childbearing potential) will be
randomized.
The study will comprise:
- A screening period of maximum 28 days
- Five treatment periods
- There will be a washout period of 3 to 6 days between dose administrations
- Follow-up visit, 5 to 7 days after last dose
Each volunteer will be involved in the study for between 7 and 9 weeks. The volunteers will
be admitted to the Unit on the day before first dosing in Treatment Period 1 until at least
72 hours after last dosing in Treatment Period 5.
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