Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
2015年4月22日 更新者：AstraZeneca
Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 500 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 500 mg Metformin (Glucophage Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
27
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Texas
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Austin、Texas、美国、78744
- PPD Development, LP
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Men and women, aged 18 to 55 years, inclusive
- Healthy participants as determined by a lack of clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
- Body Mass Index of 18 to 32 kg/m^2, inclusive
Exclusion Criteria:
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- History of allergy to DPP-4 inhibitors or related compounds
- History of allergy or intolerance to metformin or other similar acting agents
- Previous exposure to saxagliptin
- Exposure to metformin within 3 months pervious to study drug administration
- Estimated creatinine clearance of <80 mL/min using the Cockcroft Gault formula
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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其他：Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)
Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fasted state
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Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
其他名称：
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其他：Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fasted state)
Single oral dose of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet administered in the fasted state
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Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week
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其他：Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)
Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fed state
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Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
其他名称：
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其他：Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fed state)
Single oral dose of saxagliptin, 2.5 mg/metformin, 500 mg, FDC tablet administered in the fed state
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Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States
大体时间：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
大体时间：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
大体时间：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
大体时间：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States
大体时间：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
大体时间：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States
大体时间：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
大体时间：Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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Days 1, 2, and 3 of Periods 1, 2, 3, and 4
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation
大体时间：Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4
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An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment.
An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
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Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4
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Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results
大体时间：At screening visit, at Day -1 of Periods 1 through 4, and at discharge
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Clinically significant was determined by the investigator.
Hematology tests included hemoglobin, hematocrit, red blood cell count, total leukocyte count (including differential), and platelet count.
Serum chemistry tests included aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, creatinine, blood urea nitrogen, uric acid, fasting glucose, total protein, albumin, sodium, potassium, chloride, calcium, phosphorus, and creatine kinase.
Urinalysis included protein, glucose, blood, leukocyte esterase, specific gravity, and pH.
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At screening visit, at Day -1 of Periods 1 through 4, and at discharge
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Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results
大体时间：At screening visit, Day -1 of Period 1, and at study discharge
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Clinically significant was determined by the investigator.
ECGs were recorded after participants had been supine for at least 5 minutes.
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At screening visit, Day -1 of Period 1, and at study discharge
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Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate
大体时间：At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.
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Clinically significant was determined by the investigator.
Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes.
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At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年3月1日
初级完成 (实际的)
2010年3月1日
研究完成 (实际的)
2010年3月1日
研究注册日期
首次提交
2010年2月12日
首先提交符合 QC 标准的
2010年2月12日
首次发布 (估计)
2010年2月15日
研究记录更新
最后更新发布 (估计)
2015年5月12日
上次提交的符合 QC 标准的更新
2015年4月22日
最后验证
2015年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)的临床试验
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Janssen-Cilag International NV完全的