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Completed

NCT Number: NCT01156246

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

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

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Key information

Conditions

Healthy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Luleå, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy
  • BMI 18-30 kg/m2

Exclusion criteria

  • History of clinically significant illness.
  • History of alcohol or drug abuse

Treatment and study plan

Dapagliflozin/Metformin

Drug

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

Primary outcomes

  1. 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

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

    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.

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 2, 2010
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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