Healthy
Conditions
Keywords
Healthy volunteers, Dapagliflozin, Diabetes Type 2, Food interaction
Brief summary
The purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food.
Interventions
oral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3.
Sponsors
Bristol-Myers Squibb
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy * BMI 18-30 kg/m2
Exclusion criteria
* History of clinically significant illness. * History of alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Sweden
Outcome results
None listed