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Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers
Sponsor: Megalabs
Summary
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
Official title: Phase I Open and Monocentric Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Intravenous Recombinant Human Erythropoietin in Male Adults.
Key Details
Gender
MALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2024-10-06
Completion Date
2024-12
Last Updated
2024-08-21
Healthy Volunteers
Yes
Conditions
Interventions
Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU
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
Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU
Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) should be administered subcutaneously
Locations (1)
Azidus Laboratories
Chennai, India