An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on Fixed Dose Combination Dapagliflozin/Metformin Tablet (5 mg/1000 mg) in Healthy Male and Female Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Dapagliflozin/Metformin
- Conditions
- Healthy
- Sponsor
- AstraZeneca
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- To assess the effect of food on the pharmacokinetics of dapagliflozin and metformin.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food.
Investigators
Eligibility Criteria
Inclusion Criteria
- •BMI 18-30 kg/m2
Exclusion Criteria
- •History of clinically significant illness.
- •History of alcohol or drug abuse
Arms & Interventions
1
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.
Intervention: Dapagliflozin/Metformin
2
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.
Intervention: Dapagliflozin/Metformin
Outcomes
Primary Outcomes
To assess the effect of food on the pharmacokinetics of dapagliflozin and metformin.
Time Frame: 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 Outcomes
- 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.)