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OpenTrials
Completed

NCT Number: NCT00562250

Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Vicente López, Buenos Aires, 1602, Argentina

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subjects with BMI of 18-32 kg/m2

Exclusion criteria

  • Abnormal physical or lab findings
  • Allergies to any sulfonylurea or related compounds

Treatment and study plan

Dapagliflozin

Drug

Tablets, Oral, 20 mg, once daily, single dose

Glimepiride

Drug

Tablets, Oral, 4 mg, once daily, single dose

Dapagliflozin + Glimepiride

Drug

Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose

Primary outcomes

  1. Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together

    Time frame: plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose

Secondary outcomes

  1. Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride

    Time frame: for 72 hours after each administered dose

  2. Recorded adverse events

    Time frame: for 72 hours after each administered dose

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 22, 2007
Registry last updated
Oct 17, 2016

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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