Status:
COMPLETED
Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00878618
Start Date
April 1 2009
End Date
May 1 2009
Last Update
June 3 2009
Active Locations (1)
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1
Research Site
Uppsala, Sweden