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
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.
• • Age ≥ 18 years.
‣ BMI of 18.0-30.0kg/m2.
⁃ Voluntarily participants who agree to observe the precautions in writing after receiving a complete explanation of this trial.
⁃ Willingness and ability to undertake all scheduled visits and assessments.
⁃ Subject who have no evidence of underlying disease during screening, medical history and whose physical examination is performed within 28 days prior to commencement of the study.
⁃ Subjects whose screening laboratory values are within normal limits or considered by the Investigator to be of no clinical significance.
⁃ Non-smokers, ex-smokers and light smokers can be included in the study. Light smokers are defined as someone smoking \< 10 cigarettes per day, ex-smokers as someone who completely stopped smoking for at least 03 months.
⁃ No alcohol dependence, alcohol abuse or drug abuse (Amphetamines, Cocaine, Tetra Hydro Cannabinoids, Benzodiazepines, Barbiturates and Opioids) within the past one year.
⁃ Subjects should not have consumed grape fruit juice or its products 72 hours before dosing and throughout the study periods.
⁃ For Female Subjects:
• Subjects having negative urine pregnancy test.
∙ Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the Investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
∙ Postmenopausal for more than 1 year.
∙ Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).