A Bioequivalence (BE) Study Comparing The Commericializable And Clinical Formulations Of PF-00299804
2011年6月27日 更新者:Pfizer
A Phase 1 Open-Label Study Of Pf-00299804 In Healthy Volunteers To Demonstrate The Bioequivalence Of The Proposed Commercializable Formulation Administered As One 45-Mg Tablet Relative To Three 15-Mg Clinical Formulation Tablets
The study will determine if bioequivalence can be claimed between the proposed commericializable formulation and the current clinical formulation.
Specifically, if the 90% confidence intervals of the ratio for Area under the curve (AUC) and maximum concentration (CMax) are within the 80%-125% guidance limits.
研究概览
详细说明
A bioequivalence (BE) study between two formulations of PF-00299804.
研究类型
介入性
注册 (实际的)
32
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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Bruxelles、比利时、B-1070
- Pfizer Investigational Site
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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:
- Healthy subjects including males between the ages of 18 and 55 years and/or females of non childbearing potential between the ages of 18 and 55 years. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
- Evidence or history of clinically significant dermatologic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- Use of tobacco- or nicotine- containing products (or a positive urine drug cotinine test).
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study medication.
- 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
- Pregnant or nursing females and females of childbearing potential including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory FSH test results at Screening.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued at least 28 days prior to the first dose of study medication. Depo Provera must be discontinued at least 6 months prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of less than 1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
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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实验性的:Sequence 1
Subjects will receive clinical formulation (treatment A) followed by commercializable formulation (treatment B).
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Subjects to receive 3 X 15 mg tablets of the clinical formulation in first period then 1 x 45 mg tablet of the commericializable formulation in 2nd period.
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实验性的:Sequence 2
Subjects will receive commercializable formulation (treatment B) followed by clinical formulation (treatment A).
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Subjects to receive 1 x 45 mg tablet of the commericializable formulation in first period then 3X 15 mg tablets of the clinical formulation in 2nd period.
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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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Plasma AUCinf of of PF 00299804
大体时间:6-8 weeks
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6-8 weeks
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AUClast of PF 00299804
大体时间:6-8 weeks
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6-8 weeks
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Cmax of PF 00299804
大体时间:6-8 weeks
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6-8 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Plasma AUCinf of PF 00299804.
大体时间:6-8 weeks
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6-8 weeks
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CL/F of PF 00299804.
大体时间:6-8 weeks
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6-8 weeks
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Tmax of PF 00299804.
大体时间:6-8 weeks
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6-8 weeks
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tlast of PF 00299804.
大体时间:6-8 weeks
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6-8 weeks
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t1/2 of PF 00299804.
大体时间:6-8 weeks
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6-8 weeks
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Plasma AUCinf of PF-05199265
大体时间:6-8 weeks
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6-8 weeks
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AUClast of PF-05199265
大体时间:6-8 weeks
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6-8 weeks
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Cmax of PF-05199265
大体时间:6-8 weeks
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6-8 weeks
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Tmax of PF-05199265
大体时间:6-8 weeks
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6-8 weeks
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tlast of PF-05199265
大体时间:6-8 weeks
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6-8 weeks
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Safety laboratory tests, physical examination, concomitant medication and adverse event monitoring
大体时间:6-8 weeks
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6-8 weeks
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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。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2011年4月1日
初级完成 (实际的)
2011年5月1日
研究完成 (实际的)
2011年5月1日
研究注册日期
首次提交
2011年2月8日
首先提交符合 QC 标准的
2011年3月10日
首次发布 (估计)
2011年3月14日
研究记录更新
最后更新发布 (估计)
2011年6月28日
上次提交的符合 QC 标准的更新
2011年6月27日
最后验证
2011年6月1日
更多信息
与本研究相关的术语
其他研究编号
- A7471022
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.