Phase 1 study of the safety, tolerability and pharmacokinetic of CDRI Compound 97/78, a novel antimalarial drug in normal healthy human volunteers

CDRI0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Normal routine haematology (haemoglobin, total lymphocyte count, differential count, platelet count)
•Normal clinical biochemistry (SGOT, SGPT, serum bilirubin, serum creatinine, blood urea, serum electrolytes, random blood sugar, total protein, serum lipid profile)
•Normal urine and stool analysis (routine examination and microscopy)

•A history of having donated blood in the past 3 months, HIV or HBsAg positivity,
•history of any drug intake in the past 15 days, history of receiving any enzyme-inducing agent in the preceding 15 days,
•history of participating in any IND study in last 6 months,
•history of participating in any non-IND study in the past 3 months,
•history of allergy or hypersensitivity to any medication,
•history of peptic disorder,
•chronic smoker > 6 cigarettes/beedies per day, alcoholic (history of daily alcohol intake in last 6 months),
•history of any drug abuse,
•tobacco user in any form,
•history of any chronic disease and taking medication,
•history of taking non-allopathic drug in the past 6 months for any illness or history of any major illness in past (viz. meningitis, hepatitis, tuberculosis, epilepsy, nephritis having received treatment and presently asymptomatic).

发起方

CDRI