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Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00562250
First received: November 21, 2007
Last updated: November 4, 2008
Last verified: November 2008
History of Changes

November 21, 2007
November 4, 2008
May 2008
August 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00562250 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Recorded adverse events [ Time Frame: for 72 hours after each administered dose ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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
  • Experimental: Arm 1
    Intervention: Drug: Dapagliflozin
  • Active Comparator: Arm 2
    Intervention: Drug: Glimepiride
  • Active Comparator: Arm 3
    Intervention: Drug: Dapagliflozin + Glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00562250
MB102-016
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP