Study to Assess Drug Concentrations in Plasma of Different Extended-release Formulations of AZD1305
- Registration Number
- NCT00957437
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A: 3 way crossover AZD1305 AZD1305: ER test formulation 1 (w/wo food) and reference formulation Part B1: single arm AZD1305 AZD1305: ER test formulation 1 Part B2: 3 way crossover AZD1305 AZD1305: ER test formulation 2 (w/wo food) and reference formulation
- Primary Outcome Measures
Name Time Method Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma From predose until 48 hours post last dose
- Secondary Outcome Measures
Name Time Method Adverse Events, ECG variables, vital signs, physical examination, laboratory variables and weight Frequent safety measurements during the study, from screening period to follow-up
Trial Locations
- Locations (1)
Research Site
🇬🇧Harrow, United Kingdom