Pharmacokinetic study of oral tacrolimus suspensio
- Registration Number
- CTRI/2021/03/031911
- Lead Sponsor
- Indian Council of Medical Research ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relative bioavailability of Oral suspension and oral capsule (area under the concentrationâ??time curve (AUC) from time 0 to 24 hrs post-tacrolimus dose(AUC0â??24hrs); maximum observed concentration (Cmax); time to Cmax (Tmax)).Timepoint: Sample points to be collected are 0 (pre dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48h
- Secondary Outcome Measures
Name Time Method Tolerability will be assessed throughout the study.Timepoint: 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post medication