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NOT YET RECRUITING
NCT04954989
PHASE1

Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers

Sponsor: Megalabs

View on ClinicalTrials.gov

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

BIOLOGICAL

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

BIOLOGICAL

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