CTRI/2019/09/021334招募中4 期
Evaluation of Pharmacokinetics of single dose Primaquine (15mg) and its metabolite carboxymrimaquine in patients with moderate hepatic dysfunction in comparison with normal healthy participants
Seth GSMC KEM Hospital0 个研究点目标入组 0 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
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
- •For patients with hepatic dysfunction
- •1. Participants of either gender
- •2. Age 18-65yrs, both inclusive
- •3. Participants with hepatic impairment will be classified by the Modified Child-Pugh classification with Grade B (Score7-9).
- •4. Participants with Normal Renal function test.
- •5. Negative for HIV and HCV.
- •6. Peripheral smear or Rapid diagnostic test negative for malarial parasite.
- •7. Willing to give written Informed Consent and comply with all protocol requirements.
- •Inclusion criteria for normal healthy participants:
- •1. Participants of either gender
- •2. Age 18-65yrs, both inclusive.
- •3. Normal hematology, biochemistry and urine analysis.
- •4. Negative for HIV, HCV and HBsAg.
- •5. Peripheral smear or Rapid diagnostic test negative for malarial parasite.
- •6. Willing to give written Informed Consent and comply with protocol requirement.
- •7. Negative urine pregnancy test for women in the last 24 hours
排除标准
- •1. G6PD deficiency of any grade.
- •2. Participation in any clinical trial within 4 weeks prior to dosing.
- •3. History of blood donation or bleeding of 300 mL or more of blood within 8 weeks prior to study start.
- •4. History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis).
- •5. Known hypersensitivity to primaquine or related drugs (e.g., iodoquinol) as per history taking.
- •6. Persons receiving treatment with other potentially hemolytic drugs. (for tuberculosis, HIV, or any drugs that have hemolytic potential in G6PD individuals including sulphonamides, dapsone, nitrofurantoin, nalidixic acid, ciprofloxacin, methylene blue, toluidine blue, phenazopyridine, and co-trimoxazole).
- •7. Use of antimalarials within two weeks before contact with the study team as reported by the patient.[based on history taking]
- •8. Participants who vomit within 1 hour after administration of primaquine (will be removed from the analysis and will not count towards the total sample size, though they will be followed as any other enrolled individual)
- •9. Pregnancy (even if a pregnant woman is G6PD normal, the fetus may not be) and breast-feeding women.
- •10. Person on concomitant medications known to have drug-drug interactions with CYP2D6 and MAO-A.
- •11. Patients who are critically ill, those with acute hepatitis, psychiatric illnesses (delirium/encephalopathy), participants with multiple causes of hepatic impairment based on clinical judgement of the Investigator from the Department of Gastroenterology
- •12. Any other condition (for example: CCF) which the investigator believe would alter the pharmacokinetics/pharmacodynamics of the drug.
研究者
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