At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR Coadministered to Healthy Subjects in the Fed State and Steady State Pharmacokinetic Assessment of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR
In Brief
A Phase 1 clinical trial evaluating saxagliptin, Glucophage XR, and 1 other intervention for Diabetes Mellitus. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured in Mt Vernon, Indiana) and two 500 mg Glucophage XR tablets (metformin XR, manufactured in Evansville, Indiana) in the fed state in healthy subjects.
Study Details
Timeline
Interventions
Tablets, Oral, 5 mg, once daily, Single dose
Tablets, Oral, 500 mg, once daily, Single dose
Tablet, Oral, (saxagliptin 5 mg)(metformin XR 1000 mg), once daily, 4 days