NCT02253849已完成1 期
A Single Centre, Open-label Study With Healthy Adult Volunteers to Determine the Effects of Single-dose and Steady-state TPV/r 500/200 mg on the Steady-state Pharmacokinetics of Carbamazepine (200 mg Twice Daily)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Area under the concentration-time curve of Carbamazepine in plasma over the time interval t0h to t12h (AUC0-12h)
研究概览
简要总结
Study to assess the steady-state pharmacokinetics of carbamazepine (CBZ) at 200 mg or 100 mg twice daily, depending on tolerability, and administered alone and in combination with tipranavir/ritonavir (TPV/r) after a single dose (500/200 mg) and at steady-state (500/200 mg twice-daily)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 must be willing to comply with all study requirements
- •Age >19 and <59 years
- •Weight ≥ 60 kg
- •BMI >18.5 and <35 kg/m2
- •Ability to maintain adequate contraception if applicable
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- •AV block including 1°
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, 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, Ritonavir (RTV), carbamazepine 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 or during the trial)
- •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 abuse (>60 g/day)
- •Drug abuse
- •Blood donation or loss >400 mL, <1 month prior to administration or expected during the trial
- •Clinically relevant laboratory abnormalities
- •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
- •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
- •Chronic use of oral contraception or hormone replacement containing ethinyl estradiol
- •Breast-feeding
研究组 & 干预措施
CBZ - TPB/r+CBZ
Experimental
Days 1-14: carbamazepine (CBZ) twice daily
Days 15-22: CBZ twice daily plus TPV/r twice daily
干预措施: Carbamazepine (Drug)
CBZ - TPB/r+CBZ
Experimental
Days 1-14: carbamazepine (CBZ) twice daily
Days 15-22: CBZ twice daily plus TPV/r twice daily
干预措施: Tipranavir (Drug)
CBZ - TPB/r+CBZ
Experimental
Days 1-14: carbamazepine (CBZ) twice daily
Days 15-22: CBZ twice daily plus TPV/r twice daily
干预措施: Ritonavir (Drug)
结局指标
主要结局
Area under the concentration-time curve of Carbamazepine in plasma over the time interval t0h to t12h (AUC0-12h)
时间窗: up to 12 hours after drug administration
Maximum measured concentration of Carbamazepine in plasma (Cmax)
时间窗: up to 12 hours after drug administration
Drug concentration of Carbamazepine in plasma at 12 hours after drug administration (Cp12h)
时间窗: up to 12 hours after drug administration
次要结局
- AUC0-12h(up to 12 hours after drug administration)
- Cmax(up to 12 hours)
- Cp12h(up to 12 hours after drug administration)
- Clearance (CL/F)(up to 12 hours after drug administration)
- Volume of distribution(up to 12 hours after drug administration)
- Time from dosing to the maximum concentration (Tmax)(up to 12 hours after drug administration)
- t1/2 (terminal elimination half-life)(up to 12 hours after drug administration)
- Number of subjects with adverse events(up to 35 days)
- Number of subjects with clinically relevant changes in laboratory parameters(up to 35 days)
研究者
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