Bioequivalence of Saxagliptin/Metformin Extended-Release (XR) Fixed-Dose Combination Tablets and Single-Component Saxagliptin and Metformin XR Tablets in Healthy Adult Subjects

被引：0
|
作者：
David W. Boulton
Charles H. Smith
L. Li
Jian Huang
Angela Tang
Frank P. LaCreta
机构：
[1] Bristol-Myers Squibb,
[2] PPD,undefined
来源：
Clinical Drug Investigation | 2011年 / 31卷
关键词：
Metformin; Saxagliptin; Tablet Core; Healthy Adult Subject; Initial Combination Therapy;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
Background and Objectives: As compared with individual tablets, saxagliptin/metformin extended-release (XR) fixed-dose combination (FDC) tablets offer potential for increased patient compliance with the convenience of once-daily dosing. Two bioequivalence studies assessed the fed-state bioequivalence of saxagliptin/metformin XR 5 mg/500 mg FDC (study 1) and saxagliptin/metformin XR 5mg/1000 mg FDC (study 2) relative to the same dosage strengths of individual component tablets administered concurrently. The effect of food on saxagliptin and metformin pharmacokinetics from the saxagliptin/metformin XR 5 mg/500 mg FDC and their steady-state pharmacokinetics from the saxagliptin/metformin XR 5 mg/1000 mg were also investigated.
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页码：619 / 630
页数：11
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