ISRCTN24855722已完成不适用
Two-treatment, two-period, randomised, single-blind, cross-over bioequivalence of phenazopyridine HCl in 24 healthy volunteers
Phoenix International (UAE)0 个研究点目标入组 24 人开始时间: 2008年10月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- All
入选标准
- •1. Healthy subjects aged 18 to 55 (male and female)
- •2. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests
- •3. Informed consent signed by the subject
- •4. The subject is co-operative and available for the entire study
- •5. Not pregnant or nursing
- •6. Normal renal and hepatic function
排除标准
- •1. Evidence in the subject medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological or other significant acute or chronic abnormalities which might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the active agent under investigation
- •2. Hypersensitivity to subject drug, atopic eczema or allergic bronchial asthma
- •3. Evidence of hypertension (blood pressure after 3 minutes sitting >160/95 mmHg)
- •4. Evidence of chronic or acute infectious diseases
- •5. History or evidence of malignant tumours
- •6. Evidence of hyperuricaemia, elevated serum uric acid (>8.0 mg/dl)
- •7. Hepatic or renal impairment; elevated serum creatinine (>1.4 mg/dl)
- •8. Planned vaccination during the time course of the study
- •9. Adherence to a diet (e.g., vegetarian) or life style (including extreme sports) that might interfere with the investigation
- •10. Laboratory test results outside the tolerance values as laid down by the study centre, which may be an evidence of disease. Positive result of HIV1/2, Hepatitis C virus (HCV) antibody or Hepatitis B (HBs) antigen testing
- •11. Regular use of any medication within four weeks prior to commencement of the study (self-medication or prescription)
- •12. Single use of any medication (including over-the-counter medication) that are not expressively permitted within two weeks prior to start of the study
- •13. Abuse of alcohol, caffeine or tobacco (equivalent to more than 10 cigarettes a day)
- •14. Drug addiction
- •15. Participation in a clinical investigation or blood donation of more than 250 ml within the past eight weeks or blood donation of less than 250 ml within the past 4 weeks
- •16. Subjects who are known or suspected:
- •16.1. not to comply with the study directives
- •16.2. not to be reliable or trustworthy
- •16.3. not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent),in particular regarding the risks and discomfort to which they would agree to be exposed
- •16.4. to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in
研究者
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