Open label and monocentric Phase I Clinical Trial, to Determine the Pharmacokinetics and Pharmacodynamics of Recombinant Human Erythropoietin for Subcutaneous Use in an Adult Male Population
An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover design will be used to study the pharmacokinetics and pharmacodynamics of two different rHuEpo products when administered subcutaneously in healthy subjects. PK parameters to evaluate shall be AUCt and AUCt to infinity, and Cmax PD parameter shall be erithrocye and reticulocyte counts and hematocrite. Bioequivalence shall be evaluated according to 80-125 T/R rate for 90 % Cmax and AUC for pk and PD parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) of the experimental drug should be administered subcutaneously
Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) should be administered subcutaneously
Azidus Laboratories
Chennai, India
Evaluation of AUC0-inf
Area under curve Cp(t) rHuEpo from time zero to infinity
Time frame: 14 days
Evaluation Cmax
Maximum plasma concentration for rHuEpo
Time frame: 14 days
Evaluation of Emax
maximum increase in reticulocyte count
Time frame: 14 days
Evaluation of ASEC0-t
Area under curve reticulocyte count f(t) from time zero to day 14
Time frame: 14 days
half life
Compare profiles for T½ between the experimental drug and the comparator.
Time frame: 14 days
Tmax
Compare profiles for Tmax between the experimental drug and the comparator.
Time frame: 14 days
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