Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Dapagliflozin/Metformin
- Registration Number
- NCT01156246
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Healthy
- BMI 18-30 kg/m2
Exclusion Criteria
- History of clinically significant illness.
- History of alcohol or drug abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Dapagliflozin/Metformin Dapagliflozin/metformin tablet, high fat, high calorie breakfast day 1, visit 2, 7-14 days wash-out, Dapagliflozin/metformin tablet, fasting conditions day 1, visit 3. 2 Dapagliflozin/Metformin Dapagliflozin/metformin tablet, fasting conditions day 1, visit 2, 7-14 days wash-out, Dapagliflozin/metformin tablet, high fat, high calorie breakfast day 1, visit 3.
- Primary Outcome Measures
Name Time Method To assess the effect of food on the pharmacokinetics of dapagliflozin and metformin. Serial PK sampling will be done on Days 1-4 at visit 2 and 3. primary - single dose Cmax, AUCinf, AUC(0-t) of dapagliflozin and metformin.. secondary - single dose tmax, t1/2 of dapagliflozin and metformin
- Secondary Outcome Measures
Name Time Method To examine the safety and tolerability of the fixed-dose combination tablet of dapagliflozin and metformin. ECG at screening and follow-up. BP/pulse at screening, once daily during residential period and at follow-up. Clinical chemistry, haematology, and urine analyses at screening, day-1, day 4, and at follow-up. Vital signs (blood pressure and heart rate), electrocardiogram, laboratory safety data (clinical chemistry, haematology and urinalysis), adverse events.
Trial Locations
- Locations (1)
Research Site
🇸🇪Lulea, Sweden