Status:
COMPLETED
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To assess the effect of glimepiride on the PK of dapagliflozin and the effect of dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A) and to assess the effect of ...
Eligibility Criteria
Inclusion
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive BMI = weight (kg)/\[height(m)\]2
Exclusion
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
- Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN)
- History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
- History of allergy to SGLT@ inhibitors, DPP$ inhibitors or sulfonylurea or related compounds
- Prior exposure to dapagliflozin, sitagliptin and glimepiride within 3 months of Day -1
- History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00842556
Start Date
March 1 2009
End Date
May 1 2009
Last Update
October 17 2016
Active Locations (1)
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1
Ppd Development
Austin, Texas, United States, 78744