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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the mechanism of action of AZD1656 in Type 1 Diabetes Mellitus patients?
How does the tablet formulation of AZD1656 compare to oral suspension in terms of bioavailability in fasting vs. preprandial states?
Are there specific biomarkers associated with enhanced absorption or response to AZD1656 in T1DM?
What adverse events are reported with AZD1656 administration in Phase I trials for diabetes?
How does AZD1656's pharmacokinetic profile compare to other SGLT2 inhibitors in Type 1 Diabetes?
Trial Locations
- Locations (1)
Research site
🇺🇸San Antonio, Texas, United States
Research site🇺🇸San Antonio, Texas, United States