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Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects

This study has been terminated.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01068756
First received: February 12, 2010
Last updated: October 14, 2016
Last verified: October 2016

February 12, 2010
October 14, 2016
March 2010
April 2010   (final data collection date for primary outcome measure)
AUC (area under the concentration-time curve) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data [ Time Frame: Days 1 to 3 and Days 9 to 11 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01068756 on ClinicalTrials.gov Archive Site
  • Cmax (maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data [ Time Frame: Days 1 to 3 and Days 9 to 11 ] [ Designated as safety issue: No ]
  • Tmax (time of maximum observed concentration) Single dose pharmacokinetic parameter will be derived from plasma concentration versus time data [ Time Frame: Days 1 to 3 and Days 9 to 11 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects
Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects
The purpose of the study is to assess the effects of rifampin on the pharmacokinetics of dapagliflozin
Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Type 2 Diabetes Mellitus
  • Drug: Dapagliflozin
    Tablets, Oral, 10 mg, 2 single oral 10 mg doses, 2 days
  • Drug: Rifampin
    Capsules, Oral, 600 mg, Once daily on days 4 to 11, 8 days
Dapagliflozin/Rifampin
Interventions:
  • Drug: Dapagliflozin
  • Drug: Rifampin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy subjects
  • Body Mass Index (BMI) of 18 to 32 inclusive
  • Women who are not of childbearing potential and men, ages 18 to 45

Exclusion Criteria:

  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations
  • Glucosuria
  • Abnormal liver function tests
Both
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01068756
MB102-074
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