Official Title: “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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Active Comparator: Arm 2
• Active Comparator: Arm 3

Primary 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
    Safety Issue?: No

Secondary 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
    Safety Issue?: No
• Recorded adverse events
  • Time Frame: for 72 hours after each administered dose
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00562250

Study ID Number: MB102-016

ClinicalTrials.gov Identifier: NCT00562250

Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

BMS Clinical Trials Disclosure

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