NCT00961857已完成1 期
An Open-label, Randomized Two-Part, Two-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of Final Market Image (FMI) Sitagliptin /Metformin 50/500 mg and 50/1000 mg Fixed Dose Combination (FDC) and Concomitant Administration of 50 mg Doses of Sitagliptin and 500 or 1000 mg Doses of Metformin as Individual Tablets
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- The area under the plasma concentration vs. time curve (AUC) after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets
研究概览
简要总结
A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg) as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I) or Treatment C and D (Part II).
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
- •Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate contraception
- •Subject is in good health and is a non-smoker
- •Subject is willing to avoid strenuous physical activity during the study
- •Subject agrees to refrain from eating grapefruit or grapefruit products during the study
排除标准
- •Subject has a history of neoplastic disease (cancer), stroke, chronic seizures, or major neurological disorder. Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- •Subject consumes excessive amounts of alcohol or caffeinated beverages
- •Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks
- •Subject has a history of significant multiple and/or severe allergies to prescription or non-prescription drugs or food
- •Subject has a history of hypersensitivity to metformin, sitagliptin, or sitagliptin/Metformin
- •Subject is a regular user or past abuser of any illicit drugs
- •Subject is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies during the study.
- •Subject is a nursing mother
研究组 & 干预措施
Treatment A
Active Comparator
Individual Tablets of 50 mg sitagliptin and 500 mg metformin
干预措施: sitagliptin phosphate (+) metformin hydrochloride (Drug)
结局指标
主要结局
The area under the plasma concentration vs. time curve (AUC) after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets
时间窗: 72 hours post dose
次要结局
- Peak plasma concentration (Cmax) of sitagliptin and metformin after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets(72 hours post dose)
研究者
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