CTRI/2013/03/003485已完成4 期
A study on Hydroxychloroquine efficacy as an antiplatelet agent in healthy volunteers:comparison with aspirin and clopidogrel - HEAT study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- PGIMER
- 入组人数
- 20
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
入选标准
- •Normal healthy male volunteers.
- •Body weight of 55kg and above.
- •Willing to give written, informed consent.
- •Subjects with full comprehension and ability to understand the purpose and the nature of trial
- •Agreeing to refrain from smoking and alcohol during the trial period.
- •Willing to comply with protocol requirement as evidenced by informed consent documents.
- •Subjects with normal findings as determined by baseline history, Physical examination and vital signs.
- •No abnormality detected on X-ray chest & ECG.
- •No history or presence of significant alcoholism or drug abuse in the past one year.
排除标准
- •History of having donated blood in the past 3 months.
- •History of participating in any IND study in last 6 months.
- •History of participating in any non-IND study in the past 3 months.
- •Have been treated with any known enzyme inducing or inhibiting drugs within 30 days of the study.
- •History or presence of gastrointestinal disorders likely to influence drug absorption including actual GI symptoms (e.g. nausea, vomiting, diarrhoea, heart burn), preceding one week to admission.
- •Subjects with known history of /active HIV I or II, Hepatitis B or C viruses or HBsAg positivity or syphilis infection.
- •Subjects with disease of blood or haematopoietic organs (haemoglobin < 11 g/dl).
- •Subjects with abnormal renal function, (Serum Cr >1.5 mg/dl).
- •Subjects with abnormal liver function (AST and ALT, total Bilirubin, Creatinine phosphokinase or alkaline phosphatase > 2.5 times the upper limit of normal values) or active liver disease.
- •History of taking non-allopathic drug in the past 6 months for any illness.
- •Subject consuming NSAIDs or any other drug affecting coagulation, fibrinolysis or platelet function in past 15 days prior to screening.
- •Any evidence of organ dysfunction or any clinically significant deviation from the normal, in clinical or physical determination.
- •Subjects with abnormal laboratory values which are clinically significantly at screening.
- •History of depression, psychosis, schizophrenia or any other severe psychiatric diseases, or epilepsy, or any other illness that may interfere with the aim of the study.
- •History of any chronic disease or suffering from any illness during the study and requiring medication.
- •History of allergy or hypersensitivity to any of the study medication.
- •Tobacco user in any form and refusing to abstain from smoking or consumption of tobacco 72 hours before dosing until last sample collection for study.
- •History of drug dependence or excessive alcohol intake on a habitual basis of more than two units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of the study.
- •History of any other drug abuse.
研究者
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