NCT02226978已完成1 期
An Open-label One-sequence Cross-over Pharmacokinetic Interaction Study of Steady-state Tipranavir/Ritonavir 500/200 mg With Single-dose Valaciclovir (500 mg) in Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Area under the concentration-time curve of aciclovir in plasma over the time interval t0h to t12h (AUC0-12)
研究概览
简要总结
Assessment of the interaction of tipranavir/ritonavir (TPV/RTV) and valaciclovir (VAL), a prodrug of aciclovir (ACV)
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and non-pregnant, non-lactating female subjects as determined by results of screening
- •Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- •The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and willingness to comply with all study requirements
- •Age >19 and <59 years (20 - 58 years inclusive)
- •Weight ≥ 60 kg
- •Body mass index (BMI) >18.5 and <29.9 kg/m2
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- •Atrioventricular (AV) block including 1°
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, oncological or hormonal disorders
- •Surgery of gastrointestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •Relevant history of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Known hypersensitivity to TPV, RTV, valaciclovir, aciclovir or antiretroviral drugs (marketed or experimental use as part of clinical research studies)
- •Known elevated liver enzymes in past trials with any compound
- •Intake of drugs with a long half-life (>24 hours) (<1 month prior to administration)
- •Prescription or over the counter medications (including vitamins, minerals, herbal supplements and antacids), dietary supplements 14 days prior to study drug administration or expected during the trial)
- •Participation in another trial with an investigational drug (<2 months prior to administration or expected during trial)
- •Smoker with a consumption of >10 cigarettes or >3 cigars or >3 pipes/day and those who cannot keep tobacco intake constant
- •Alcohol (>40 g/day for males and >20 g/day for females) and drug abuse
- •Blood donation or loss >400 mL, < 3 month prior to administration
- •Clinically relevant laboratory abnormalities
- •Transaminases above reference values in the history
- •Inability to comply with dietary regimen of study centre
- •For female subjects:
- •Pregnancy or planning to become pregnant within 60 days of study completion
- •Positive pregnancy test
- •Have not been using a barrier method of contraception for at least 3 months prior to participation in the study if of childbearing potential and not surgically sterilized
- •Are not willing or are unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial if of childbearing potential and not surgically sterilized
- •Chronic use of oral contraception or hormone replacement containing ethinyl estradiol
- •Breast-feeding
研究组 & 干预措施
TPV/r with valaciclovir
Experimental
VAL 2 days (on days 1 and 13), TPV/r 12 days (on days 2 to 13)
干预措施: Tipranavir (Drug)
TPV/r with valaciclovir
Experimental
VAL 2 days (on days 1 and 13), TPV/r 12 days (on days 2 to 13)
干预措施: Ritonavir (Drug)
TPV/r with valaciclovir
Experimental
VAL 2 days (on days 1 and 13), TPV/r 12 days (on days 2 to 13)
干预措施: Valaciclovir (Drug)
结局指标
主要结局
Area under the concentration-time curve of aciclovir in plasma over the time interval t0h to t12h (AUC0-12)
时间窗: up to 12 hours after drug administration
Maximum measured concentration of aciclovir in plasma (Cmax)
时间窗: up to 12 hours after drug administration
次要结局
- AUC0-12 for Tipranavir (TPV)(up to 12 hours after drug administration)
- Cmax for TPV(up to 12 hours after drug administration)
- Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)(up to 12 hours after drug administration)
- Terminal half-life of the analyte in plasma (t1/2)(up to 12 hours after drug administration)
- Number of subjects with adverse events(up to 14 days after last drug administration)
- Number of subjects with clinically significant findings in laboratory tests(up to 14 days after last drug administration)
- AUC0-12 for Ritonavir (RTV)(up to 12 hours after drug administration)
- Cmax for RTV(up to 12 hours after drug administration)
- Drug concentration of RTV in plasma at 12 hours after administration (C12h)(up to 12 hours after drug administration)
- Drug concentration of TPV in plasma at 12 hours after administration (C12h)(up to 12 hours after drug administration)
- Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)(up to 12 hours after drug administration)
研究者
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