A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions
2013年3月1日 更新者：Janssen R&D Ireland
A Single-Dose, Open-Label, 3-Panel, Randomized, Pivotal Crossover Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat as Either a Fixed Dose Combination Tablet (G006) or as Single Agents Under Fed and Fasted Conditions in Healthy Subjects
The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg tablets of the commercial tablet formulation, in the presence of 150 mg cobicistat, (under fed and fasted conditions) in healthy participants.
研究概览
详细说明
This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), 3-panel, single-center, single-dose, crossover (method used to switch patients from one treatment arm to another in a clinical trial) study in 134 healthy adult participants.
The study consists of 3 phases including a screening phase of approximately 3 weeks (Days -21 to -1) followed by an open-label treatment phase consisting of 3 panels with 2 single-dose treatment sessions of 5 days each (Days -1 to 4) separated by a washout period of at least 7 days, and a follow-up period occurring 7 to 10 days after last intake of study drugs.
The study consists of 3 panels.
In each panel participants will be randomly be assigned to 1 of 2 treatment sequences (AB or BA for Panel 1; CD or DC for Panel 2; and EF or FE for Panel 3).
Participants will receive either single-dose darunavir 800 mg as 2 x 400 mg tablets and cobicistat 150 mg tablet or single-dose darunavir/cobicistat 800/150 mg as tablet in each panel (under fed and fasted conditions).
研究类型
介入性
注册 (实际的)
133
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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Merksem、比利时
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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 60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:
- Participant should be healthy on the basis of physical examination, medical history, vital signs, and electrocardiogram and clinical laboratory tests performed at screening
- Have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included
- Men and women must agree to use a highly effective method of birth control
Exclusion Criteria:
- Has a positive HIV-1 or HIV-2 test at screening
- Has a Hepatitis A, B or C infection (confirmed by hepatitis A antibody immunoglobulin M (IgM), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody, respectively) at screening
- Has any history of renal insufficiency
- Has a history of significant skin reactions or any history of allergies to drugs
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
- 主要用途：治疗
- 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：Treatment A
Single-dose co-administration of 800 mg darunavir and 150 mg cobicistat as single agents (under fasted condition)
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Type=exact number, unit=mg, number=400, form=tablet, route=oral.
Two tablets as a single dose or a tablet in combination with cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral.
One tablet as a single dose or a tablet in combination with darunavir
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实验性的：Treatment B
Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fasted condition).
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Type=exact number, unit=mg, number=400, form=tablet, route=oral.
Two tablets as a single dose or a tablet in combination with cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral.
One tablet as a single dose or a tablet in combination with darunavir
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实验性的：Treatment C
Single-dose co-administration of 800 mg darunavir and 150 mg cobicistat as single agents (under fed condition - standardized breakfast).
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Type=exact number, unit=mg, number=400, form=tablet, route=oral.
Two tablets as a single dose or a tablet in combination with cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral.
One tablet as a single dose or a tablet in combination with darunavir
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实验性的：Treatment D
Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fed condition - standardized breakfast).
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Type=exact number, unit=mg, number=400, form=tablet, route=oral.
Two tablets as a single dose or a tablet in combination with cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral.
One tablet as a single dose or a tablet in combination with darunavir
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|
实验性的：Treatment E
Single-dose co-administration of the fixed dose combination darunavir/cobicistat 800/150-mg (under fasted condition).
|
Type=exact number, unit=mg, number=400, form=tablet, route=oral.
Two tablets as a single dose or a tablet in combination with cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral.
One tablet as a single dose or a tablet in combination with darunavir
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实验性的：Treatment F
Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fed condition - high-fat breakfast).
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Type=exact number, unit=mg, number=400, form=tablet, route=oral.
Two tablets as a single dose or a tablet in combination with cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral.
One tablet as a single dose or a tablet in combination with darunavir
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Comparison of maximum plasma analyte concentration (Cmax) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)
大体时间：Up to 27 Days
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The pharmacokinetic parameter (Cmax) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg).
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Up to 27 Days
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Comparison of last observed measurable analyte concentration (Clast) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)
大体时间：Up to 27 Days
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The pharmacokinetic parameter (Clast) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg).
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Up to 27 Days
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Comparison of actual sampling time to reach the maximum plasma analyte concentration (tmax) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)
大体时间：Up to 27 Days
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The pharmacokinetic parameter (tmax) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg) for assessment of bioequivalance.
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Up to 27 Days
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Area under curve from time of administration up to the last time point with a measurable plasma analyte concentration (AUClast) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)
大体时间：Up to 27 Days
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The pharmacokinetic parameter (AUClast) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg).
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Up to 27 Days
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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 adverse events as a measure of safety and tolerabilty
大体时间：Up to 27 Days
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Safety and tolerability of darunavir/cobicistat co-administration in healthy participants will be assessed by number of participants with adverse events.
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Up to 27 Days
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Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet
大体时间：Up to 27 Days
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Plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet under fed conditions in healthy participants will be evaluated.
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Up to 27 Days
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Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents
大体时间：Up to 27 Days
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Plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents under fed conditions in healthy participants will be evaluated.
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Up to 27 Days
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Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet
大体时间：Up to 27 Days
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Plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet under fasted conditions in healthy participants will be evaluated.
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Up to 27 Days
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Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents
大体时间：Up to 27 Days
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Plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents under fasted conditions in healthy participants will be evaluated
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Up to 27 Days
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Evaluation of effect of a high-fat meal on darunavir and cobicistat pharmacokinetics relative to the fasted state
大体时间：Up to 27 Days
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Effects of a high-fat meal on darunavir and cobicistat pharmacokinetics relative to the fasted state will be evaluated.
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Up to 27 Days
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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。
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
2012年4月1日
初级完成 (实际的)
2012年8月1日
研究完成 (实际的)
2012年8月1日
研究注册日期
首次提交
2012年6月12日
首先提交符合 QC 标准的
2012年6月13日
首次发布 (估计)
2012年6月14日
研究记录更新
最后更新发布 (估计)
2013年3月4日
上次提交的符合 QC 标准的更新
2013年3月1日
最后验证
2013年3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.
darunavir的临床试验
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Emory UniversityCenters for Disease Control and Prevention完全的
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University of British ColumbiaGilead Sciences完全的
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Southern Illinois Healthcare FoundationJanssen Scientific Affairs, LLC完全的
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Fundación Pública Andaluza para la Investigación...Merck Sharp & Dohme LLC未知