Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single doses of Cudafol(R) and Diprivan(R) in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
8
Test product Cudafol(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes
Reference product Diprivan(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes
Bioequivalence based on pharmacokinetic parameter: Area Under Curve
Time frame: 0-24 hours post dose
Bioequivalence based on pharmacokinetic parameter: Cmax
Time frame: 0-24 hours post dose
Pharmacokinetic parameter: Tmax
Time frame: 0-24 hours post dose
Incidence of adverse events and tolerability
Number of adverse events and local tolerability
Time frame: 7 days post dose
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