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An randomly assigned, two-treatment, balanced, single dose study to evaluate the Pharmacokinetics and Pharmacodynamics of Intravenous Injection of REPOITIN and Human Serum Albumin - Free REPOITIN Injection of Serum Institute compared to licensed EPO injection injection in healthy adult subjects

AN OPEN-LABEL, RANDOMIZED, THREE-PERIOD, THREE-TREATMENT, THREE-SEQUENCE, CROSSOVER, BALANCED, SINGLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS AND PHARMACODYNAMICS OF INTRAVENOUS INJECTION OF REPOITIN INJECTION (TEST 1) 10000 IU/mL AND HUMAN SERUM ALBUMIN - FREE REPOITIN INJECTION (TEST 2) 10000 IU/mL OF SERUM INSTITUTE OF INDIA LTD COMPARED TO A LICENSED RECOMBINANT HUMAN ERYTHROPOIETIN INJECTION (REFERENCE) 10000 IU IN HEALTHY HUMAN ADULTS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/11/006383
Enrollment
66
Registered
2015-11-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Repoitin: Repoitin - A pre-filled syringe of 1.0 ml contains 10,000 IU of epoetin alfa. Dose â?? 100 IU/Kg of body weight Route of administration - Intravenous Manufactured by: Serum In

Sponsors

Serum Institute of India Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1.Subjects with any previous exposure to erythropoiesis stimulating agents. 2.History of allergy of biological products derived from mammalian albumin 3.Any disease or condition which might compromise any body system.

Design outcomes

Primary

MeasureTime frame
To compare pharmacokinetics of single intravenous dose of Repoitin and Human Serum Albumin - Free Repoitin with a licensed Recombinant Human Erythropoietin Injection 10000 IU.Timepoint: In each period, total 25 venous blood samples will be collected at different time points pre dose and post dose in labeled SST vacutainers.—

Secondary

MeasureTime frame
To compare pharmacodynamics of single intravenous 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—

Countries

India

Contacts

Public ContactDr Sajjad A Desai

Serum Institute of India Ltd.

drpsk@seruminstitute.com020-26602384

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026