A study in healthy volunteers to determine whether different drugs metabolised by the liver have any effects on how NRL972 is processed within the body.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
Single intravenous administration of 2 mg NRL972 after pre-treatment with 600 mg p.o. rifampicin once daily from the evening of Day D-7 until the evening of Day D-1
Reference test: Single intravenous administration of 2 mg NRL972
Single intravenous administration of 2 mg NRL972 injection after pre-treatment with 100 mg cyclosporine on the evening of Day D-1 and on the morning of Day D01 one hour before administration of NRL972
Dept. Clinical Pharmacology & Therapeutics, MHAPT "Zaritza Johanna" University Hospital
Sofia, Bulgaria
Total clearance by non-compartmental analysis. Apparent terminal disposition half-life t½ by non-compartmental analysis
Time frame: Up to 6 hours post dose
Non-compartmental PK-analysis based on the extensive profile (up to last quantifiable data point), the 'short' profile (over the first hour after injection), and the two-point profile based on selected data-pairs over the 1st hour after dosing
Time frame: Up to 6 hours post dose
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