Healthy Thai volunteers Healthy volunteers
Conditions
Interventions
Erythropoietin-SBS 4000 IU, 0.4 ml in syringe
Manufactured: API, Formulated bulk &
Fill finished by Siam Bioscience Co., Ltd., Thailand
,Hema-Plus 4000 prefilled syringes
Manufactured: API &
Formulated bulk by Center of Molecular Immunology (CIM), Republic of Cuba
Aseptic Refilled, Quality control and released by Siam Bioscience Co., Ltd., Thailand
Experimental Biological/Vaccine,Active Comparator Biological/Vaccine
Erythropoietin-SBS,Hema-Plus
Sponsors
Siam Bioscience Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Thai subjects are between 18 to 55 years of age 2. The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2 3. Healthy, no history of evidence of chronic disease or severe disorder 4. No history of usually smoking (more than 10 cigarettes per day within past 1 year) 5. No history of alcoholism (more than 2 years) 6. Negative pregnancy test for women and no breast-feeding
Exclusion criteria
Exclusion criteria: 1. History or evidence of allergy or hypersensitivity to Epoetin alfa or product derived from mammalian cells or human albumin or any related drugs or any of the excipients of this product 2. Subject with BP is Systolic BP below 85, from 130 mm/Hg and over; Diastolic BP below 60, from 90 mm/Hg and over; Pulse rate over 100 bpm 3. Serum bilirubin greater than 1.5 times ULRR 4. Serum creatinine greater than 1.5 times ULRR 5. Alanine amino transferase or aspartate amino transferase greater than 2 times ULRR 6. Positive of hepatitis B or C virus 7. Have more than one abnormal EKG, which is considered as clinically significant 8. History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, glaucoma, thrombotic vascular events, cerebrovascular accidents 9. History of epilepsy or seizures 10. History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy 11. Any major illness in the past 3 months or any significant ongoing chronic medical illness 12. History of psychiatric disorder 13. History of regular alcohol consumption and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study 14. History of usually smoking, if moderate smokers cannot stop at least 7 days before the study drug administration and until the completion of each period of the study 15. High caffeine consumption and cannot stop at least 2 days before the study drug administration until the completion of each period of the study 16. Positive drug abused test in urine 17. Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) 18. History of difficulty in accessibility of veins in left and right arm 19. Blood donation within the past 3 months before the study 20. Participation in any clinical study within the past 3 months before the study 21. Subjects who are unwilling or unable to comply with this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax and AUC0-72 pre-dose (0.00 hour) and at 1.0, 3.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 14.0, 16.0, 24.0, 48.0 and 72.0 hours after dosing Erythropoietin plasma concentration by ELISA | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, Half-life, Kel, ratio AUC0-t and AUC0-infinity pre-dose (0.00 hour) and at 1.0, 3.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 14.0, 16.0, 24.0, 48.0 and 72.0 hours after dosing Erythropoietin plasma concentration by ELISA,Safety The subjects will be monitored for adverse events throughout the entire confinement periods and all AEs reported by the subjects or observed by the investigators Adverse events | — |
Countries
Thailand
Contacts
Public ContactPreechanoot Aimruen
Siam Bioscience
Outcome results
None listed