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Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00562250
First received: November 21, 2007
Last updated: October 14, 2016
Last verified: October 2016
November 21, 2007
October 14, 2016
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 ]
Same as current
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 ]
  • Recorded adverse events [ Time Frame: for 72 hours after each administered dose ]
Same as current
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
Intervention Model: Crossover Assignment
Masking: None (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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Argentina
United States
 
NCT00562250
MB102-016
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
October 2016

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