Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00562250
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
- Healthy subjects with BMI of 18-32 kg/m2
Exclusion Criteria
- Abnormal physical or lab findings
- Allergies to any sulfonylurea or related compounds
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 3 Dapagliflozin + Glimepiride - Arm 1 Dapagliflozin - Arm 2 Glimepiride -
- Primary Outcome Measures
Name Time Method Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose
- Secondary Outcome Measures
Name Time Method Recorded adverse events for 72 hours after each administered dose Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride for 72 hours after each administered dose
Trial Locations
- Locations (1)
Local Institution
🇦🇷Vicente Lopez, Buenos Aires, Argentina