An randomly assigned, two-treatment, balanced, single dose study to evaluate the Pharmacokinetics and Pharmacodynamics of subcutaneous Injection of REPOITIN and Human Serum Albumin - Free REPOITIN Injection of Serum Institute compared to licensed EPO injection injection in healthy adult subjects
Not Applicable
Completed
- Registration Number
- CTRI/2015/04/005670
- Lead Sponsor
- Serum Institute of India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
1.Able to give written informed consent to participate in the study
2.Healthy adult males and/or females aged between 18-45 years (including both)
3.Subjects weight within normal range with minimum of 50 kg weight
4.Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range
Exclusion Criteria
1.Subjects with any previous exposure to erythropoiesis stimulating agents.
2.History of allergy of biological products derived from mammalian albumin or any component of the study drug formulation
3.Any disease or condition which might compromise any body system.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To compare pharmacokinetics of single subcutaneous dose of Repoitin and Human Serum Albumin - Free Repoitin with a licensed Recombinant Human Erythropoietin Injection 10000 IUTimepoint: In each period, total 27 venous blood samples will be collected at different time points pre dose and post dose
- Secondary Outcome Measures
Name Time Method â?¢To compare pharmacodynamics of single subcutaneous dose of Repoitin and Human Serum Albumin - Free Repoitin with a licensed Recombinant Human Erythropoietin Injection 10000 IU.Timepoint: In each period, total 11 venous blood samples will be collected at different time points pre dose and post dose