None listed
Conditions
Interventions
Intervention1: Extemporaneous oral suspension of Tacrolimus: Each volunteer in this arm will be given equivalent dose of extemporaneous oral suspension of tacrolimus
Control Intervention1: Tacrolimus
Sponsors
Indian Council of Medical Research ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Tolerability will be assessed throughout the study.Timepoint: 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post medication | — |
Countries
India
Contacts
Public ContactDr Avaneesh Kumar Pandey
PGIMER Chandigarh
Outcome results
None listed