Pharmacokinetic evaluation of extemporaneous tacrolimus oral suspension

Indian Council of Medical Research ICMR0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Normal healthy male volunteers.
•- Age 18 - 50 yrs
•- Willing to give written, informed consent
•- Willing to comply with protocol requirements
•- Normal physical & systemic examination
•- Biochemistry & hematology (within 15% of laboratory range will be acceptable)
•- No abnormality detected on X-ray chest & ECG
•- No known contraindication to tacrolimus
•- No clinical and laboratory evidence of hepatic, renal or cardiac dysfunction or hypertension.

•History of having donated blood in the past 3 months.
•- HIV or HBs Ag positivity
•- History of any drug intake in the past 15 days
•- History of receiving any enzyme-inducing agent in the past 30 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 ulcer or gastro intestinal perforation
•- History of infectious illness in past six months
•- Past history of malignancy
•- History of renal disease
•- History of neuropathy or neurological disease
•- History of hematological disorders
•- History of any drug abuse
•- history of respiratory disorder (Asthma, COPD)
•- History of any other chronic disease and taking medication
•- H/o of taking non-allopathic drug in the past 6 months for any illness
•- History of any major illness in past that, in the opinion of the investigators, can interfere with participant safety or study evaluation
•- Dyselectrolytemia
•- Chronic smoker >6 cigarettes/beedies per day
•-Any rate/rhythm disturbance as detected in ECG or in medical history
•- Alcoholic (history daily alcohol intake in last 6 months)
•- Tobacco user in any form

发起方

Indian Council of Medical Research ICMR