Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | August 2012 |
| End Date: | October 2012 |
| Contact: | For participation information at a USA site use a phone number below. For Site information outside USA please email: |
| Email: | Clinical.Trials@bms.com |
A Single-dose, Open-label, Randomized, 3 Period, 3 Treatment Crossover Study to Evaluate the Pharmacokinetics of Saxagliptin 5 mg and Dapagliflozin 10 mg When Coadministered to Fasted Healthy Subjects
The purpose of this study is to evaluate whether the pharmacokinetics (body
concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when
they are administered together
Inclusion Criteria:
- Healthy subjects as determined by no clinically significant deviation from normal in
medical history, PE, vital signs, 12-lead ECG, and clinical laboratory determinations
- Body mass index (BMI) of 18 to 30 kg/m2
- Men and women, ages 18 to 45 years
- Women of childbearing potential must use acceptable methods of highly effective birth
control
Exclusion Criteria:
- History of chronic or recurrent urinary tract infection for females
- History of allergies or adverse reactions to Dipeptidyl peptidase-IV (DPP4) or
Sodium-glucose transporter type 2 (SGLT2) inhibitors
- Any significant acute or chronic medical illness
- Current or recent gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- Prior exposure to saxagliptin or dapagliflozin or related drugs
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