An Open-Label, Randomized, Two-Period Crossover Definitive Bioequivalence Study With the Final Marketed Image (FMI) Sitagliptin/Metformin Fixed-Dose Combination (FDC) Tablet and Co-Administration of the Sitagliptin and Metformin Individual Tablets After Consumption of a High-Fat Meal in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 主要终点
- Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin
研究概览
简要总结
This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •is in good health
- •is a nonsmoker
- •is willing to follow all study guidelines
排除标准
- •has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the participant
- •is a nursing mother
- •is unwilling to consume the required high-fat breakfast
研究组 & 干预措施
Sita + Met then Sita/Met FDC
Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2.
干预措施: Sitagliptin phosphate/metformin hydrochloride FDC (Drug)
Sita + Met then Sita/Met FDC
Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2.
干预措施: Sitagliptin phosphate (Drug)
Sita + Met then Sita/Met FDC
Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2.
干预措施: Metformin hydrochloride (Drug)
Sita/Met FDC then Sita + Met
Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
干预措施: Sitagliptin phosphate/metformin hydrochloride FDC (Drug)
Sita/Met FDC then Sita + Met
Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
干预措施: Sitagliptin phosphate (Drug)
Sita/Met FDC then Sita + Met
Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
干预措施: Metformin hydrochloride (Drug)
结局指标
主要结局
Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin
时间窗: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose
Serum samples were used to determine the AUC from time 0 to infinity for metformin.
次要结局
- Peak Plasma Concentration (Cmax) of Metformin(Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose)