To Evaluate the Bioavailability of a Tablet of AZD1656
- Registration Number
- NCT00817505
- Lead Sponsor
- AstraZeneca
- Brief Summary
To evaluate the bioavailability of a tablet of AZD1656.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
- Male or female, type I diabetes patients, female with non child-bearing potential.
- Treated with insulin for more than 3 years. Well controlled HbA1c.
- Have a body mass index (BMI) ≥19 and ≤35
Exclusion Criteria
- Clinically significant illness except type I diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
- Daily use of nicotine containing substances.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 AZD1656 AZD1656 susp. without food 3 AZD1656 AZD1656 tablet 1 AZD1656 AZD1656 tablet + food
- Primary Outcome Measures
Name Time Method Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F) Blood samples taken up to 72 hours
- Secondary Outcome Measures
Name Time Method Pharmacodynamic variables (Plasma glucose) Taken repeatedly during treatment periods Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables) Taken during treatment periods
Trial Locations
- Locations (1)
Research site
🇺🇸San Antonio, Texas, United States