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PK, PD, Safety and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex (Janssen-Cilag).
Sponsor: Incepta Pharmaceuticals Ltd
Summary
Erythropoietin is a glycoprotein which stimulates red blood cell production. It is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. Erythropoietin, a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous erythropoietin. Erythropoietin binds to the surface receptor of erythroid precursor cells and activates signal transduction pathways that interfere with apoptosis and stimulates erythroid cell proliferation. Recombinant human erythropoietin is a substitute for the deficiency observed in CKD, therapy of anemia often involves many other issues such as Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy, Anemic patients (hemoglobin \> 10 to \< 13 g/dL) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions, Anemia related to therapy with zidovudine in HIV-infected patients are also needed to be considered in order to effectively correct anemia, reduce costs and minimize side effects.
Official title: Randomized, Double-blinded, Two-treatment, Two-periods, Single-dose, Crossover, PK, PD, Safety, and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex of Janssen-Cilag Ltd in Healthy Adult Subjects
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2025-04-24
Completion Date
2025-12-31
Last Updated
2025-06-17
Healthy Volunteers
Yes
Conditions
Interventions
Erythropoietin alfa
Erythropoietin 4000 IU Injection, for subcutaneous injection.
Locations (1)
Universal Medical College and Hospital
Dhaka, Dhaka Division, Bangladesh