EUCTR2005-004905-27-GB进行中（未招募）1 期
Pharmacokinetic Interactions between Ciprofloxacin and Chloroquine / Proguanil Prophylaxis
Dstl0 个研究点目标入组 16 人开始时间: 2007年2月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
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
- •To participate in this study, subjects must meet the following criteria:
- •1. Ability and willingness to give written informed consent prior to study participation
- •2. Healthy male subjects aged between 18 and 50 years (inclusive)
- •3. Body Mass Index (BMI) within the range of > 21 and < 30 kg/m2
- •4. Vital signs within the following ranges:
- •Pulse rate 40-90 bpm
- •Systolic blood pressure 90-140 mmHg
- •Diastolic blood pressure 50-90 mmHg
- •5. Ability to communicate well with the Investigator and to comply with the requirements of the study.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects meeting any of the following criteria will be excluded from participation in the study:
- •1. Presence of any clinically significant medical condition as determined by the Medical Advisor
- •2. Any clinically significant haematological or biochemical abnormality as determined by the Medical Advisor
- •3. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug (e.g. renal or liver disease, respiratory, immunological, endocrine or neurological disorders)
- •4. Any ECG abnormality other than sinus bradycardia or respiratory sinus arrhythmia
- •5. Known or suspected hypersensitivity or idiosyncratic reaction related to any of the investigational medicinal products
- •6. Positive test for hepatitis B surface antigen
- •7. History or evidence of alcohol abuse defined as an intake of more than 28 units per week (4 units per day), where 1 unit corresponds to 250 ml beer, 20 ml spirits/liqueur or one glass (100 ml) of wine
- •8. Participation in another clinical study within the three months prior to screening
- •9. Use of any prescription medication within the 14 days prior to screening
- •10. Use of any non-prescription medication within the last 7 days (apart from paracetamol), which may, in the opinion of the Medical Advisor, impact the safety aspects and/or objectives of the study
- •11. Donation of blood or blood products within the 3 months prior to screening, or the intention to donate blood or blood products within 3 months after completion of the study.
研究者
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