Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants

Completed · Phase 1

Conditions studied: Type 2 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT01662999

Run by

AstraZeneca

People needed

42

Starts

2012-08-01

Expected to finish

2012-11-01

Last updated by the study team

2015-05-08

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, Physical Examination, 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

You may not qualify if…

• 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

Where it is running

• Icon Clinical Pharmacology — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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