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

AstraZeneca18 enrolled

Overview

The purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Dapagliflozin/MetforminDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy * BMI 18-30 kg/m2 Exclusion Criteria: * History of clinically significant illness. * History of alcohol or drug abuse

Locations (1)

Research Site

Luleå, Sweden

Outcomes

Primary Outcomes

To assess the effect of food on the pharmacokinetics of dapagliflozin and metformin.

primary - single dose Cmax, AUCinf, AUC(0-t) of dapagliflozin and metformin.. secondary - single dose tmax, t1/2 of dapagliflozin and metformin

Time frame: Serial PK sampling will be done on Days 1-4 at visit 2 and 3.

Secondary Outcomes

To examine the safety and tolerability of the fixed-dose combination tablet of dapagliflozin and metformin.

Vital signs (blood pressure and heart rate), electrocardiogram, laboratory safety data (clinical chemistry, haematology and urinalysis), adverse events.

Time frame: 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.

Data from ClinicalTrials.gov

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