A Phase 1 interventional study of Saxagliptin in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-05.
Sponsored by AstraZeneca · Phase 1 and Interventional
To characterize the steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects
9,357 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 12 is below the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Exclusion Criteria:
Drug: Saxagliptin
Tablets, oral, 2.5 mg, twice daily, 7 days
Also known as: Onglyza™
Evidence of steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects
Time frame: Within the first 24 hours of dosing
To characterize the steady-state pharmacodynamics of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects
Time frame: 18 time points up to 14 hours on two separate study days
To assess the PK of the pharmacologically active major metabolite of saxagliptin, BMS-510849, following administration of 2.5 mg saxagliptin twice daily with meals to healthy subjects
Time frame: 21 time points up to 23 hours after first dosing
To assess the safety and tolerability of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects
Time frame: Day 1 to Day 7
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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