CTRI/2015/11/006383已完成未知
AN OPEN-LABEL, RANDOMIZED, THREE-PERIOD, THREE-TREATMENT, THREE-SEQUENCE, CROSSOVER, BALANCED, SINGLE DOSE STUDYTO 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
Serum Institute of India Ltd0 个研究点目标入组 66 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •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
排除标准
- •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.
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