Status:
COMPLETED
Study to Assess Drug Concentrations in Plasma of Different Extended-release Formulations of AZD1305
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.
Eligibility Criteria
Inclusion
- Provision of signed, written and dated informed consent prior to any study specific procedures.
- Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
Exclusion
- History or presence of any clinically significant disease or disorder in the opinion of the investigator.
- Use of nicotine in the last 4 weeks before screening and not more than 7 cigarettes per week (equivalent to 1 nicotine patch or 7 nicotine gums per week) before then. There will be no smoking until follow-up visit.
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00957437
Start Date
August 1 2009
End Date
November 1 2009
Last Update
November 26 2009
Active Locations (1)
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1
Research Site
Harrow, United Kingdom