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Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00562250
First Posted: November 22, 2007
Last Update Posted: October 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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

Condition Intervention Phase
Diabetes Mellitus, Type 2 Drug: Dapagliflozin Drug: Glimepiride Drug: Dapagliflozin + Glimepiride Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • Recorded adverse events [ Time Frame: for 72 hours after each administered dose ]

Enrollment: 11
Study Start Date: May 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Dapagliflozin
Tablets, Oral, 20 mg, once daily, single dose
Active Comparator: Arm 2 Drug: Glimepiride
Tablets, Oral, 4 mg, once daily, single dose
Active Comparator: Arm 3 Drug: Dapagliflozin + Glimepiride
Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562250


Locations
Argentina
Local Institution
Vicente Lopez, Buenos Aires, Argentina, 1602
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00562250     History of Changes
Other Study ID Numbers: MB102-016
First Submitted: November 21, 2007
First Posted: November 22, 2007
Last Update Posted: October 17, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors