ISRCTN20647977已完成4 期
Pharmacokinetic Interactions between Ciprofloxacin and Chloroquine/Proguanil Prophylaxis in healthy young males: a randomised, parallel-group, open label study
Defence Science and Technology Laboratory (Dstl)0 个研究点目标入组 16 人开始时间: 2019年4月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
入排标准
- 性别
- Male
入选标准
- •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:
- •4.1. Pulse rate 40-90 bpm
- •4.2. Systolic blood pressure 90-140 mmHg
- •4.3. Diastolic blood pressure 50-90 mmHg
- •5. Ability to communicate well with the Investigator and to comply with the requirements of the study.
排除标准
- •1. Presence of any clinically significant medical condition as determined by the Investigator or Medical Advisor
- •2. Any clinically significant haematological or biochemical abnormality as determined by the Investigator or 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 or Hepatitis C antibody
- •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 Investigator or 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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Pharmacokinetic Interactions between Ciprofloxacin and Chloroquine / Proguanil ProphylaxisChloroquine/proguanil is used for malaria chemoprophylaxis in areas where chloroquine-resistant Plasmodium falciparum malaria is prevalent, except in regions of Africa where chloroquine/proguanil is no longer effective. Ciprofloxacin is a fluoroquinolone antibiotic used to treat a wide variety of infections, such as traveller`s diarrhoea. Only healthy subjects will be treated in this study.EUCTR2005-004905-27-GBDstl16
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