EUCTR2013-001976-39-NL进行中（未招募）不适用
Randomized, open-label, crossover study into the contribution of the intestines and kidney in the diurnal variation of Levofloxacin pharmacokinetics - Diurnal variation of levofloxacin pharmacokinetics
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1.Healthy male subjects (Caucasians), 18 to 50 years of age, inclusive. Health status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urinalysis.
- •2.Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg.
- •3.Regular bedtimes (between 23:00 and 24:00h) and wake-up times (between 07:00 and 08:00) from one week prior to the study.
- •4.Ability to communicate well with the investigator in the Dutch language.
- •5.Ability to participate and willing to give written informed consent and to comply with the study restrictions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.History of clinically significant haematologic, renal, hepatic, cardiovascular, neurologic, endocrinal, oncologic, pulmonary, immunologic, or psychiatric disorders;
- •2.Positive for hepatitis B, C or Human Immunodeficiency Virus (HIV);
- •3.Positive drug screen result (i.e. positive for cocaine, opiates, amphetamine, cannabis and/or benzodiazepines) at screening and before drug administration;
- •4.Positive alcohol breath test result at screening or before drug administration;
- •5.Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg;
- •6.Any of the following findings in the resting ECG:
- •a.Screening or baseline ECG with QRS and/or T wave judged to be unfavourable for a consistently accurate QT measurement (e.g., neuromuscular artefact that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U waves);
- •b.QTcB> 450 or < 300 msec at screening or baseline visit;
- •7.Use of prescription medication within 2 weeks prior to drug administration;
- •8.Use of over-the-counter medication (including homeopathic medicines and vitamins) within 3 days prior to Day 1. An exception is paracetamol (up to 4 g/day). Other exceptions will only be made if the rationale is discussed and clearly documented by the Investigator.
- •9.History of seizures or any disorder that predispose to seizures;
- •10.Personal or family history of congenital long QT syndrome or sudden death;
- •11.History of clinically significant allergies, including relevant drug hypersensitivity or allergy;
- •12.Presence or history of alcoholism or drug abuse;
- •13.Use of more than 21 units of alcohol per week;
- •14.Use of more than 8 units of caffeine per day;
- •15.Smoking (subjects had to be non-smokers for at least 90 days preceding Screening);
- •16.Transmeridian flights or shift work within a month prior to the start of the study;
- •17.Extreme morning and evening types (determined by the Horne-Ostberg Morningness/Eveningness Questionnaire).
- •18.Participation in another clinical trial within 3 months prior to the start of this study or more than 4 times a year;
- •19.Loss of blood over 500 mL within 3 months prior to screening;
- •20.Unsuitable to participate in the study for any reason in the opinion of the PI.
研究者
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