Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN) Coadministered to Healthy Subjects in a Fed Condition.
Phase of Trial: Phase I
Latest Information Update: 28 May 2015
At a glance
- Drugs Metformin; Saxagliptin; Saxagliptin/metformin
- Indications Type 2 diabetes mellitus
- Focus Pharmacokinetics
- Sponsors Bristol-Myers Squibb
- 08 Nov 2010 Extended-release saxagliptin/metformin [KOMBIGLYZE XR] has received FDA approval for the treatment of type 2 diabetes mellitus, according to a Bristol-Myers Squibb media release.
- 08 Sep 2010 New trial record