Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
Condition: Anemia
Intervention: Epoetin Alfa 40000 UNT/ML
Intervention description: 40.000 UI subcutaneous single dose
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Pharmacokinetic/Pharmacodynamic Study of 3 Epoetin Alfa Formulations in Single Subcutaneous
      Doses Administered to Healthy Volunteers

      SPONSOR Biosidus S.A.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          1. Subjects of both sexes aged 21 - 55 years old.

          2. Baseline Hb levels between 11 and 14 in women and between 12 and 15 g/ dl in men.

          3. Body Mass Index (BMI) between 19 and 27 kg/ m2.

          4. Volunteers whose additional tests (ECG, blood, and urine), performed before their
             inclusion, are within the normal limits and/ or with no clinical significance based on
             the investigator's judgment. Women of childbearing potential should have a negative
             pregnancy test and use a safe contraceptive method during the study (UID or a
             similarly effective method).

          5. Subjects with systolic blood pressure higher than 100 mm Hg and lower than 139 mm Hg,
             diastolic blood pressure higher than 70 mm Hg and lower than 89 mm H, heart rate
             higher than 50 and lower than 90 heartbeats per minute after 5 minutes in sitting
             position and then in standing position (extreme values included).

          6. Volunteers who are well disposed to the study and have signed the approved informed
             consent before the beginning of the study.

        EXCLUSION CRITERIA:

          1. History of clinically significant allergies (except untreated asymptomatic seasonal
             allergies).

          2. Decrease of more than 20 mm Hg in systolic blood pressure or more than 10 mm Hg in
             diastolic blood pressure within the first 3 minutes after the change in body position.

          3. Volunteers who are or have been taking other drugs (prescription or over - the -
             counter) within two weeks before the study.

          4. Volunteers with a history of autoimmune diseases.

          5. Organic CNS, psychological, or psychiatric disorders: epilepsy, manic - depressive
             tendencies, serious depressive episodes, insomnia, changes in personality.

          6. Active infections.

          7. Having received live or killed virus or bacteria vaccines within a month before
             inclusion.

          8. Allergic to epoetin alfa or related substances, to human albumin, or any of the
             ingredients of the formulations.

          9. Previous exposure to recombinant epoetin.

         10. Active smoker (more than 10 cigarettes/ day).

         11. Current clinical evidence of severe digestive disorders.

         12. Current clinical evidence of kidney diseases.

         13. Current evidence of liver disorders.

         14. Current clinical evidence of respiratory or heart diseases.

         15. Diabetes mellitus, thyroid dysfunction, or other endocrine disorders.

         16. Evidence of active gastroduodenal disease.

         17. History of peripheral thrombotic events.

         18. An underlying neurological disorder.

         19. Current presence of a malignant disease.

         20. History of drug or alcohol abuse or addiction within the past three years.

         21. History of drug or alcohol abuse within the past two years.

         22. Participation in a clinical study within the past three months.

         23. A subject who donated or lost blood within three months before the beginning of the
             study, or who intends to donate blood within three months after the end of the study.

         24. Heavy drinker of tea, cocoa, mate, coffee, and/ or caffeinated drinks (> 5 cups/ day)
             or alcohol (> 50 ml/ day).

         25. Electrocardiogram abnormalities.

         26. Positive HIV, hepatitis B, or hepatitis C serological testing.

         27. Abnormal clinical laboratory results (considered as clinically significant by the
             physician).

         28. Volunteers who have received oral iron supplements within the last month.

         29. If Hb exceeds 18 g/ dl on the 504 - hour control before each treatment phase,
             confirmed by repetition of the analysis.

         30. Women who do not use an effective contraceptive method (IUD, condom).

         31. Pregnancy and breastfeeding.

         32. Uncooperative volunteer.