NL-OMON32330尚未招募不适用
A Phase I, open-label, randomized, 2-way crossover trial in 40 healthy subjects to investigate the potential pharmacokinetic interactions between telaprevir and darunavir/ritonavir and between telaprevir and fosamprenavir/ritonavir at steady-state - An interaction study of telaprevir in combination with DRV/rtv or fAPV/rtv
TIBOTEC PHARMACEUTICALS In Nederland vertegenwoordigd door Janssen-Cilag B.V. afdeling GCO0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational invasive
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-male or female aged between 18-55 year
- •-females should be amenorrheal for at least 3 years, or post-hystorectomy or post-tubal ligation
- •-nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day
- •-normal weight at screening (BMI 18-30 kg/m2)
- •-healthy based on the assessments performed at screening
排除标准
- •-subjects with a history of any illness that, in the opinion of the investigator or the subject*s general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
- •-current use of prescription medication
- •-Regular treatment with over-the-counter medications. Subjects should stop over-the-counter medications on the date of the Screening Visit but no less than 7 days prior to the first administration of study medication
- •-consumption of herbal medication or dietary supplements and grapefruit and grapfruit juice, apple juice, orange juice within 14 days before first administration of studymedication
- •-consumption of more than 2 units alcoholic beverages per dag er 14 per week
- •-consumption of more an avarage of more than 5 servings of coffee or other caffeinated beverages per day
- •-a history of drug or alcohol abuse or addiction, or who test positive for alcohol or drugs such as cannabis, cocaine, amphetamines, benzodiazepines, or opiates during the screening period
- •-participation in a clinical study involving administration of an investigational drug within 3 months
- •-donation of any blood or having had a significant loss of blood within 3 months
- •-positive test for any of the following infectious disease tests: hepatitis A infection (confirmed by hepatitis A antibody IgM), hepatitis B antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus 1 antibody (HIV1Ab), or human immunodeficiency virus 2 antibody (HIV2Ab)
- •-male subjects with female partners that are pregnant, or planning to become pregnant during the study or within 90 days of the last dose of study medication
- •-having participated previously in a trial with telaprevir (VX-950)
研究者
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