NCT02194218已完成1 期
An Open-label, Randomised, Single Dose, Parallel-group Phase I Study to Investigate the Pharmacokinetic Properties of 200 mg Nevirapine Extended Release Tablets When Administered Orally as 2x100 mg Tablets or as 4x50 mg Tablets in Healthy Male 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
- 48
- 主要终点
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
研究概览
简要总结
Study to determine the pharmacokinetic properties of 200 mg nevirapine (NVP) administered as 4 x 50 mg extended release (XR) tablets in a single dose and to establish the bioequivalence of this formulation compared to 200 mg NVP administered as 2 x 100 mg XR tablets in a single dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male according to the following criteria based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory; values within normal ranges or deviating from normal without clinical relevance as considered by the investigator
- •Age ≥21 and Age ≤50 years
- •Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- •Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation
排除标准
- •Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- •Any evidence of a clinically relevant concomitant disease
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders of clinical relevance
- •Surgery of the gastrointestinal tract (except appendectomy and herniotomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of relevant orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- •Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- •Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- •Participation in another trial with an investigational drug within two months prior to administration or during the trial
- •Previous intake of Nevirapine
- •Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (more than 30 g/day)
- •Drug abuse
- •Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- •Excessive physical activities (within one week prior to administration or during the trial)
- •Any laboratory value outside the reference range that is of clinical relevance
- •Inability to comply with dietary regimen of trial site
研究组 & 干预措施
Nevirapine XR 4 doses
Experimental
干预措施: Nevirapine, low dose (Drug)
Nevirapine XR 2 doses
Active Comparator
干预措施: Nevirapine, high dose (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
时间窗: up to 144 hours post-dose
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: up to 144 hours post-dose
次要结局
- Terminal half-life of the analyte in plasma (t1/2)(up to 144 hours post-dose)
- Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)(up to 144 hours post-dose)
- Absorption rate constant (ka)(up to 144 hours post-dose)
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)(up to 144 hours post-dose)
- Assessment of tolerability by investigator on a 4-point scale(within 8 days after last trial procedure)
- Terminal rate constant in plasma (λz)(up to 144 hours post-dose)
- Number of patients with adverse events(up to 35 days)
- Time from dosing to the maximum concentration of the analyte in plasma (tmax)(up to 144 hours post-dose)
- Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)(up to 144 hours post-dose)
- Mean residence time of the analyte in the body after po administration (MRTpo)(up to 144 hours post-dose)
研究者
相似试验
已完成
2 期
Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric PatientsHIV InfectionsNCT00273975Boehringer Ingelheim123
进行中（未招募）
1 期
A pharmacokinetic study to assess Nevirapine levels in HIV-infected patients with impaired hepatic function.Treatment of HIV infectionEUCTR2005-000175-17-ES60
已完成
1 期
A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.HIV InfectionsNCT00905489Boehringer Ingelheim85
已完成
1 期
A Pharmacokinetic Study of Narlaprevir as a Single Dose or With Ritonavir Combination in Patients With Hepatic Impairment and Healthy Matched VolunteersHepatic ImpairmentNCT03832426R-Pharm32
终止
1 期
Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine, Abacavir and Amprenavir in HIV-1 Infected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Naive AdultsHIV InfectionsNCT02182765Boehringer Ingelheim8