CTRI/2011/06/001794招募中4 期
EVALUATION OF PHARMACOKINETICS OF SINGLE DOSE PRIMAQUINE (15 mg) IN PATIENTS WITH HEPATIC DYSFUNCTION - NI
I0 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
- 招募中
- 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. Participants classified by the Modified Child-Pugh Classification as having Grade A (mild) (Score of 5-6) or Grade B (moderate)(Score7-9) hepatic impairment
- •2. Participants with Normal Renal profile
- •3. Peripheral smear negative for malarial parasite
- •4. Willing to give written Informed Consent & comply with protocol requirement
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 300 mL 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, urticaria, eczematous dermatitis)
- •4.Participants having WBC count of less than 3000/cmm
- •5.Any gastrointestinal disorder like diarrhea, constipation within 7 days before enrollment
- •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 (even if a pregnant woman is G6PD normal, the fetus may not be) & breast feeding women
- •10.Participants of Arthritis, Psoriasis, SLE, DLE
- •11.History of surgical portosystemic shunt.
研究者
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