Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers

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

Sponsors

Lead Sponsor: AstraZeneca

Collaborator: Bristol-Myers Squibb

Source 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.

Overall Status Completed
Start Date June 2010
Completion Date August 2010
Primary Completion Date August 2010
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
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.
Secondary Outcome
Measure Time Frame
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.
Enrollment 18
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dapagliflozin/Metformin

Description: oral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3.

Eligibility

Criteria:

Inclusion Criteria:

- Healthy

- BMI 18-30 kg/m2

Exclusion Criteria:

- History of clinically significant illness.

- History of alcohol or drug abuse

Gender: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility: Research Site
Location Countries

Sweden

Verification Date

May 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

Description: 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.

Label: 2

Type: Experimental

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov