Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837

A Phase I, Single-Centre, Open, Randomized, Two-Way Crossover Study to Evaluate the Pharmacokinetics of the Extended-Release Test Formulation of AZD0837 Compared to the Extended-Release AZD0837 Reference Formulation After Repeated Dosing in Healthy Volunteers

The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the oral doses of the extended-release test- and reference formulations of AZD0837 in healthy volunteers both in fasting and fed conditions.

Inclusion Criteria:

• Healthy subject aged between 18 to 45 years inclusive
• Body mass index (BMI) between 19 to 30 kg/m2 inclusive
• Body weight between 50 to 100 kg inclusive
• Women must be either post-menopausal, permanently sterilised or, if of childbearing potential, must have a negative pregnancy test before intake of study medication and use a reliable form of contraception before and during participation in the study.

Exclusion Criteria:

• Significant illness (including ongoing or history of liver disease), trauma or surgical procedures from 2 weeks before the pre-entry visit until the first administration of Investigational Product
• Clinical significant abnormalities in clinical chemistry, haematology or urinalysis result including positive result on screening tests for serum hepatitis B surface antigen, hepatitis C antibody or HIV or positive F-Hb result pre-entry
• History of bleeding disturbance (including extensive menstrual bleedings) or thrombotic disorder
• Clinically significant medical history, as judged by the investigator, including psychiatric disorders or severe allergies.