CTRI/2010/091/000356已完成4 期
Evaluation of pharmacokinetics of single dose primaquine (15mg) in patients with renal dysfunction
Self funded0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 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
入选标准
- •1. Subject of either gender
- •2. Age between 18-60 years
- •3. Subjects classified by NKF-KDOQI guidelines
- •Group 1: 15.29ml/mns/1.73sq.mt, Group 2: <15 ml/min/1.73sq.mt
排除标准
- •1. Participation in any clinical trial or investigational new drug study within 4 weeks prior to dosing
- •2. Donation or loss of 300ml or more of blood within 8 weeks prior to study start
- •3. History of asthma and chronic obstructive pulmonary disease, treated or not treated or clinically significant drug allergy, history of atopic allergy (asthma, utricaria, eczematous dermatitis)
- •4. Peripheral smear positive for malarial parasite
- •5. Any gastrointestinal disorder like diarrhea, constipation within 7 days
- •6. G6PD deficiency
- •7. Known hypersensitivity to primaquine or related drugs (e.g. iodoquinol) as per history taking
- •8. Persons receiving treatment with other potentially hemolytic drugs
- •9. Pregnancy and breast feeding
- •10. History of surgical portosytemic shunt
研究者
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